Back to resultsEvaluation of a Transfusion Therapy Using Whole Blood in the Management of Coagulopathy in Patients With Acute Traumatic Hemorrhage (T-STORHM)
Primary Purpose
Trauma, Acute Hemorrhage, Coagulopathy
Status
Recruiting
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Whole blood transfusion
Fractionated blood products transfusion
Sponsored by
About this trial
This is an interventional treatment trial for Trauma focused on measuring Whole Blood, Acute traumatic coagulopathy, Transfusion
Eligibility Criteria
Inclusion Criteria:
Severe trauma patients requiring the initiation of a massive transfusion protocol determined on
At least two Red flag score factors (according to pre-hospital data) :
- Suspected pelvic fracture
- Shock index (FC / PAS)> = 1
- Microdose hemoglobin <13g
- Average blood pressure <70 mmHg
- Need for prehospital tracheal intubation
AND at least two criteria of the Assessment of Blood Consumption (ABC) score established at the patient's arrival:
- Penetrating trauma
- Focused Abdominal Sonography for Trauma (FAST) echo positive
- Blood pressure <90 mmHg
- Respiratory rate >120 bpm
- AND/OR on the prediction of the practitioner (clinical diagnosis) in charge of the treatment of the injured person of the need to transfuse at least 4 PRBCs within 6 hours after the admission of the trauma patient
Exclusion Criteria:
- Non-traumatic hemorrhage
- Patients transfused with more than two PRBCs before the initiation of the massive transfusion protocol.
- Anti-coagulation treatment
- Pregnancy
- Age < 18 years
- Patient refusing administration of blood products
- Patient transferred from another hospital
- Patient nor transported by a physician-staffed prehospital emergency medical system
- Burn patient (≥30% of body surface).
- No affiliated to the social security
- Person deprived of liberty by a legal or administrative decision, person under guardianship
Sites / Locations
- CHU de La Cavale Blanche - Brest
- HIA PercyRecruiting
- CHU de GrenobleRecruiting
- CHU de La Pitié-Salpêtrière
- CHU du Kremlin Bicêtre
- HIA Sainte AnneRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Whole blood group
Fractionated blood products group
Arm Description
Damage control resuscitation for trauma care using whole blood.
Damage control resuscitation for trauma care using component therapy.
Outcomes
Primary Outcome Measures
Non inferiority on the correction of coagulopathy, during emergency transfusion of bleeding trauma using whole blood compared to the use of component therapy (packed red blood cells, plasma units and platelets).
This outcome is measured on the correction of traumatic coagulopathy, measured by the value of a viscoelastometric parameter : the maximum amplitude (MA) (measured by a thromboelastogram).
Secondary Outcome Measures
Effectiveness of circulatory resuscitation
Proportion of patients with lactate clearance > 20% per hour at H2.
Mortality
Number of deaths.
Mortality / Morbidity
Composite endpoint : Number of deaths at H24 or impairment of vital functions with a Sequential Organ Failure Assessment (SOFA) score greater than or equal to 12.
Impact on timeframe to obtain blood products
Time to obtain product ratios in accordance with recommendations.
Impact on time to start transfusion therapy
Time to start transfusion therapy.
Evolution of coagulopathy.
All the parameters of the thrombelastography (TEG) (R/CK, alpha/CK, MA/CRT, LY30/CK, FF/CRT) allow to evaluate the coagulopathy.
Evolution of coagulopathy
All the parameters of the coagulation (PT, APTT, fibrinogene) allow to evaluate the coagulopathy.
Tolerance of whole blood transfusion
Hemolysis marker rate
Labile blood products transfused in the first 24 hours
Number of bags administered
Cost of the strategy
Direct costs of transfusion and the cost of the ICU stay
Biobank establishment
To constitute biobank for biological measurements in research hemorrhagic shock pathophysiology of transfusion resuscitation.
Ancillary study n°1 : recirculation of storage microerythrocytes
Rate of storage microerythrocytes, monocyte quantification and phenotyping, splenic ultrasound
Ancillary study n°2 : evolution of microcirculation during transfusion resuscitation of hemorrhagic shock.
Optical imaging technique of microvascular content to detect flow anomalies in microvessels.
Full Information
NCT ID
NCT04431999
First Posted
May 28, 2020
Last Updated
May 16, 2023
Sponsor
Direction Centrale du Service de Santé des Armées
Collaborators
TIMC-IMAG, Floralis
1. Study Identification
Unique Protocol Identification Number
NCT04431999
Brief Title
Evaluation of a Transfusion Therapy Using Whole Blood in the Management of Coagulopathy in Patients With Acute Traumatic Hemorrhage
Acronym
T-STORHM
Official Title
Evaluation of a Transfusion Therapy Using Whole Blood Versus Fractionated Blood Products in the Management of Coagulopathy in Patients Admitted to Hospital for Acute Traumatic Hemorrhage
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 4, 2021 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Direction Centrale du Service de Santé des Armées
Collaborators
TIMC-IMAG, Floralis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The prognosis of traumatized hemorrhages is correlated with the nature of transfusion therapy: a 50% reduction in mortality for an early and massive supply of plasma, and 20% for an early and massive supply of platelets. However, this strategy encounters logistical difficulties, particularly in a context of collective emergency (attacks). The use of whole blood, widely documented by the Armed Forces, improves the availability of plasma and platelets, and simplifies handling by the various actors in the chain.
T-STORHM is a randomized, controlled, parallel clinical trial.This study tests non-inferiority of whole blood transfusion therapy in the management of coagulopathy in patients with acute traumatic hemorrhage.
Detailed Description
In recent years, terrorist attacks have confronted the investigator's healthcare system with a massive influx of victims of war weapon injuries. This new fact makes the efficiency of transfusion therapy crucial: hemorrhage is the leading cause of death from weapons of war, and the high number of victims of each attack changes the logistical approach.
The logistical problems with transfusion therapy, including red blood cell (PRBCs), plasma and platelet concentrates, are the speed of delivery and availability. Using whole blood is a pragmatic solution to overcome these problems. This solution has been used for many years by the French Army to ensure platelet transfusion in traumatic hemorrhages
The hypothesis of the T-STORHM study is that the use of whole blood is a solution in a context of civil trauma not effective less than component therapy (PRBCs, plasma and platelet concentrates) in the management of coagulopathy in patients admitted to hospital for traumatic hemorrhage.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma, Acute Hemorrhage, Coagulopathy
Keywords
Whole Blood, Acute traumatic coagulopathy, Transfusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Multicenter, Controlled, Randomized, Open Labe Therapeutic Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Whole blood group
Arm Type
Experimental
Arm Description
Damage control resuscitation for trauma care using whole blood.
Arm Title
Fractionated blood products group
Arm Type
Active Comparator
Arm Description
Damage control resuscitation for trauma care using component therapy.
Intervention Type
Drug
Intervention Name(s)
Whole blood transfusion
Intervention Description
Severe trauma patients with a life threatening bleeding will be managed with 3 whole blood bags for the 1st and 2nd pack. The later packs will consist of 3 packed red blood cells (PRBCs), 3 plasma units and 1 dose of platelets.
Intervention Type
Drug
Intervention Name(s)
Fractionated blood products transfusion
Intervention Description
Severe trauma patients with a life threatening bleeding will be managed with 3 packed red blood cells (PRBCs), 3 lyophilised plasma units and 1 dose of platelets for the 1st. The 2nd pack will consist of 3 packed red blood cells (PRBCs) and 3 lyophilised plasma units. Then, the later pack will consist of 3 packed red blood cells (PRBCs), 3 plasma units and 1 dose of platelets.
Primary Outcome Measure Information:
Title
Non inferiority on the correction of coagulopathy, during emergency transfusion of bleeding trauma using whole blood compared to the use of component therapy (packed red blood cells, plasma units and platelets).
Description
This outcome is measured on the correction of traumatic coagulopathy, measured by the value of a viscoelastometric parameter : the maximum amplitude (MA) (measured by a thromboelastogram).
Time Frame
6 hours following hospital admission
Secondary Outcome Measure Information:
Title
Effectiveness of circulatory resuscitation
Description
Proportion of patients with lactate clearance > 20% per hour at H2.
Time Frame
2 hours following hospital admission
Title
Mortality
Description
Number of deaths.
Time Frame
2 hours following hospital admission and Day 30 (or the last day of hospitalization)
Title
Mortality / Morbidity
Description
Composite endpoint : Number of deaths at H24 or impairment of vital functions with a Sequential Organ Failure Assessment (SOFA) score greater than or equal to 12.
Time Frame
24 hours following hospital admission
Title
Impact on timeframe to obtain blood products
Description
Time to obtain product ratios in accordance with recommendations.
Time Frame
2 and 6 hours following hospital admission
Title
Impact on time to start transfusion therapy
Description
Time to start transfusion therapy.
Time Frame
Time between admission and transfusion therapy
Title
Evolution of coagulopathy.
Description
All the parameters of the thrombelastography (TEG) (R/CK, alpha/CK, MA/CRT, LY30/CK, FF/CRT) allow to evaluate the coagulopathy.
Time Frame
At inclusion, 2, 6 and 24 hours following hospital admission
Title
Evolution of coagulopathy
Description
All the parameters of the coagulation (PT, APTT, fibrinogene) allow to evaluate the coagulopathy.
Time Frame
At inclusion, 2, 6 and 24 hours following hospital admission.
Title
Tolerance of whole blood transfusion
Description
Hemolysis marker rate
Time Frame
Day 1, Day 2
Title
Labile blood products transfused in the first 24 hours
Description
Number of bags administered
Time Frame
24 hours following hospital admission
Title
Cost of the strategy
Description
Direct costs of transfusion and the cost of the ICU stay
Time Frame
Day 30 (or the last day of hospitalization)
Title
Biobank establishment
Description
To constitute biobank for biological measurements in research hemorrhagic shock pathophysiology of transfusion resuscitation.
Time Frame
Through study completion, an average of 3 years
Title
Ancillary study n°1 : recirculation of storage microerythrocytes
Description
Rate of storage microerythrocytes, monocyte quantification and phenotyping, splenic ultrasound
Time Frame
before and after transfusion resuscitation, Day 30 (or the last day of hospitalization).
Title
Ancillary study n°2 : evolution of microcirculation during transfusion resuscitation of hemorrhagic shock.
Description
Optical imaging technique of microvascular content to detect flow anomalies in microvessels.
Time Frame
During the transfusion resuscitation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Severe trauma patients requiring the initiation of a massive transfusion protocol determined on
At least two Red flag score factors (according to pre-hospital data) :
Suspected pelvic fracture
Shock index (FC / PAS)> = 1
Microdose hemoglobin <13g
Average blood pressure <70 mmHg
Need for prehospital tracheal intubation
AND at least two criteria of the Assessment of Blood Consumption (ABC) score established at the patient's arrival:
Penetrating trauma
Focused Abdominal Sonography for Trauma (FAST) echo positive
Blood pressure <90 mmHg
Respiratory rate >120 bpm
AND/OR on the prediction of the practitioner (clinical diagnosis) in charge of the treatment of the injured person of the need to transfuse at least 4 PRBCs within 6 hours after the admission of the trauma patient
Exclusion Criteria:
Non-traumatic hemorrhage
Patients transfused with more than two PRBCs before the initiation of the massive transfusion protocol.
Anti-coagulation treatment
Pregnancy
Age < 18 years
Patient refusing administration of blood products
Patient transferred from another hospital
Patient nor transported by a physician-staffed prehospital emergency medical system
Burn patient (≥30% of body surface).
Patient under specific known transfusion protocol (for example : allo immunization...)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sylvain AUSSET
Phone
+33 4 72 36 40 01
Email
sylvain.ausset@def.gouv.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Christophe RENARD
Phone
+33 1 40 51 41 03
Email
christophe1.renard@intradef.gouv.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathalie KOULMANN
Organizational Affiliation
Direction Centrale du Service de Santé des Armées (DCSSA)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sylvain AUSSET
Organizational Affiliation
Ecoles militaires de santé de Lyon-Bron
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean-Luc BOSSON
Organizational Affiliation
Statistical and methodological investigator - Laboratoire TIMC UMR 5525 CNRS Equipe Themas
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de La Cavale Blanche - Brest
City
Brest
ZIP/Postal Code
29200
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe ARIES
Email
philippe.aries@chu-brest.fr
Facility Name
HIA Percy
City
Clamart
ZIP/Postal Code
92140
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre PASQUIER
Email
pierre.pasquier@intradef.gouv.fr
Facility Name
CHU de Grenoble
City
Grenoble
ZIP/Postal Code
38000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre BOUZAT
Email
PBouzat@chu-grenoble.fr
Facility Name
CHU de La Pitié-Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathieu RAUX
Email
mathieu.raux@aphp.fr
Facility Name
CHU du Kremlin Bicêtre
City
Paris
ZIP/Postal Code
94270
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathieu RAUX
Email
mathieu.raux@aphp.fr
Facility Name
HIA Sainte Anne
City
Toulon
ZIP/Postal Code
83000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Meaudre
Email
eric.meaudre-desgouttes@intradef.gouv.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28333835
Citation
Spinella PC. Zero preventable deaths after traumatic injury: An achievable goal. J Trauma Acute Care Surg. 2017 Jun;82(6S Suppl 1):S2-S8. doi: 10.1097/TA.0000000000001425. No abstract available.
Results Reference
background
PubMed Identifier
23021369
Citation
Bhangu A, Nepogodiev D, Doughty H, Bowley DM. Meta-analysis of plasma to red blood cell ratios and mortality in massive blood transfusions for trauma. Injury. 2013 Dec;44(12):1693-9. doi: 10.1016/j.injury.2012.07.193. Epub 2012 Sep 25.
Results Reference
background
PubMed Identifier
22787340
Citation
Johansson PI, Oliveri RS, Ostrowski SR. Hemostatic resuscitation with plasma and platelets in trauma. J Emerg Trauma Shock. 2012 Apr;5(2):120-5. doi: 10.4103/0974-2700.96479.
Results Reference
background
PubMed Identifier
25340382
Citation
Cap A, Hunt B. Acute traumatic coagulopathy. Curr Opin Crit Care. 2014 Dec;20(6):638-45. doi: 10.1097/MCC.0000000000000158.
Results Reference
background
PubMed Identifier
30189070
Citation
Cap AP, Pidcoke HF, Spinella P, Strandenes G, Borgman MA, Schreiber M, Holcomb J, Tien HC, Beckett AN, Doughty H, Woolley T, Rappold J, Ward K, Reade M, Prat N, Ausset S, Kheirabadi B, Benov A, Griffin EP, Corley JB, Simon CD, Fahie R, Jenkins D, Eastridge BJ, Stockinger Z. Damage Control Resuscitation. Mil Med. 2018 Sep 1;183(suppl_2):36-43. doi: 10.1093/milmed/usy112.
Results Reference
background
PubMed Identifier
30917843
Citation
Spahn DR, Bouillon B, Cerny V, Duranteau J, Filipescu D, Hunt BJ, Komadina R, Maegele M, Nardi G, Riddez L, Samama CM, Vincent JL, Rossaint R. The European guideline on management of major bleeding and coagulopathy following trauma: fifth edition. Crit Care. 2019 Mar 27;23(1):98. doi: 10.1186/s13054-019-2347-3.
Results Reference
background
PubMed Identifier
27799173
Citation
Godier A, Bacus M, Kipnis E, Tavernier B, Guidat A, Rauch A, Drumez E, Susen S, Garrigue-Huet D. Compliance with evidence-based clinical management guidelines in bleeding trauma patients. Br J Anaesth. 2016 Nov;117(5):592-600. doi: 10.1093/bja/aew317.
Results Reference
background
PubMed Identifier
26841720
Citation
Stanworth SJ, Davenport R, Curry N, Seeney F, Eaglestone S, Edwards A, Martin K, Allard S, Woodford M, Lecky FE, Brohi K. Mortality from trauma haemorrhage and opportunities for improvement in transfusion practice. Br J Surg. 2016 Mar;103(4):357-65. doi: 10.1002/bjs.10052. Epub 2016 Feb 3.
Results Reference
background
PubMed Identifier
28754492
Citation
Carli P, Pons F, Levraut J, Millet B, Tourtier JP, Ludes B, Lafont A, Riou B. The French emergency medical services after the Paris and Nice terrorist attacks: what have we learnt? Lancet. 2017 Dec 16;390(10113):2735-2738. doi: 10.1016/S0140-6736(17)31590-8. Epub 2017 Jul 25. No abstract available.
Results Reference
background
PubMed Identifier
23192066
Citation
Eastridge BJ, Mabry RL, Seguin P, Cantrell J, Tops T, Uribe P, Mallett O, Zubko T, Oetjen-Gerdes L, Rasmussen TE, Butler FK, Kotwal RS, Holcomb JB, Wade C, Champion H, Lawnick M, Moores L, Blackbourne LH. Death on the battlefield (2001-2011): implications for the future of combat casualty care. J Trauma Acute Care Surg. 2012 Dec;73(6 Suppl 5):S431-7. doi: 10.1097/TA.0b013e3182755dcc. Erratum In: J Trauma Acute Care Surg. 2013 Feb;74(2):706. Kotwal, Russell S [corrected to Kotwal, Russ S].
Results Reference
background
PubMed Identifier
21795876
Citation
Eastridge BJ, Hardin M, Cantrell J, Oetjen-Gerdes L, Zubko T, Mallak C, Wade CE, Simmons J, Mace J, Mabry R, Bolenbaucher R, Blackbourne LH. Died of wounds on the battlefield: causation and implications for improving combat casualty care. J Trauma. 2011 Jul;71(1 Suppl):S4-8. doi: 10.1097/TA.0b013e318221147b.
Results Reference
background
PubMed Identifier
23928738
Citation
Glasgow S, Davenport R, Perkins Z, Tai N, Brohi K. A comprehensive review of blood product use in civilian mass casualty events. J Trauma Acute Care Surg. 2013 Sep;75(3):468-74. doi: 10.1097/TA.0b013e318298efb9. No abstract available.
Results Reference
background
PubMed Identifier
27100758
Citation
Doughty H, Glasgow S, Kristoffersen E. Mass casualty events: blood transfusion emergency preparedness across the continuum of care. Transfusion. 2016 Apr;56 Suppl 2:S208-16. doi: 10.1111/trf.13488.
Results Reference
background
PubMed Identifier
24750387
Citation
Glasgow SM, Allard S, Rackham R, Doughty H. Going for gold: blood planning for the London 2012 Olympic Games. Transfus Med. 2014 Jun;24(3):145-53. doi: 10.1111/tme.12116. Epub 2014 Apr 18.
Results Reference
background
PubMed Identifier
22809430
Citation
Glasgow SM, Allard S, Doughty H, Spreadborough P, Watkins E. Blood and bombs: the demand and use of blood following the London Bombings of 7 July 2005--a retrospective review. Transfus Med. 2012 Aug;22(4):244-50. doi: 10.1111/j.1365-3148.2012.01173.x.
Results Reference
background
PubMed Identifier
23426594
Citation
Radwan ZA, Bai Y, Matijevic N, del Junco DJ, McCarthy JJ, Wade CE, Holcomb JB, Cotton BA. An emergency department thawed plasma protocol for severely injured patients. JAMA Surg. 2013 Feb;148(2):170-5. doi: 10.1001/jamasurgery.2013.414.
Results Reference
background
PubMed Identifier
21332727
Citation
de Biasi AR, Stansbury LG, Dutton RP, Stein DM, Scalea TM, Hess JR. Blood product use in trauma resuscitation: plasma deficit versus plasma ratio as predictors of mortality in trauma (CME). Transfusion. 2011 Sep;51(9):1925-32. doi: 10.1111/j.1537-2995.2010.03050.x. Epub 2011 Feb 18.
Results Reference
background
PubMed Identifier
30030268
Citation
Cardenas JC, Zhang X, Fox EE, Cotton BA, Hess JR, Schreiber MA, Wade CE, Holcomb JB; PROPPR Study Group. Platelet transfusions improve hemostasis and survival in a substudy of the prospective, randomized PROPPR trial. Blood Adv. 2018 Jul 24;2(14):1696-1704. doi: 10.1182/bloodadvances.2018017699.
Results Reference
background
PubMed Identifier
25647203
Citation
Holcomb JB, Tilley BC, Baraniuk S, Fox EE, Wade CE, Podbielski JM, del Junco DJ, Brasel KJ, Bulger EM, Callcut RA, Cohen MJ, Cotton BA, Fabian TC, Inaba K, Kerby JD, Muskat P, O'Keeffe T, Rizoli S, Robinson BR, Scalea TM, Schreiber MA, Stein DM, Weinberg JA, Callum JL, Hess JR, Matijevic N, Miller CN, Pittet JF, Hoyt DB, Pearson GD, Leroux B, van Belle G; PROPPR Study Group. Transfusion of plasma, platelets, and red blood cells in a 1:1:1 vs a 1:1:2 ratio and mortality in patients with severe trauma: the PROPPR randomized clinical trial. JAMA. 2015 Feb 3;313(5):471-82. doi: 10.1001/jama.2015.12.
Results Reference
background
PubMed Identifier
23560283
Citation
Holcomb JB, del Junco DJ, Fox EE, Wade CE, Cohen MJ, Schreiber MA, Alarcon LH, Bai Y, Brasel KJ, Bulger EM, Cotton BA, Matijevic N, Muskat P, Myers JG, Phelan HA, White CE, Zhang J, Rahbar MH; PROMMTT Study Group. The prospective, observational, multicenter, major trauma transfusion (PROMMTT) study: comparative effectiveness of a time-varying treatment with competing risks. JAMA Surg. 2013 Feb;148(2):127-36. doi: 10.1001/2013.jamasurg.387.
Results Reference
background
PubMed Identifier
22847102
Citation
Cap AP, Spinella PC, Borgman MA, Blackbourne LH, Perkins JG. Timing and location of blood product transfusion and outcomes in massively transfused combat casualties. J Trauma Acute Care Surg. 2012 Aug;73(2 Suppl 1):S89-94. doi: 10.1097/TA.0b013e318260625a.
Results Reference
background
PubMed Identifier
28207628
Citation
Fox EE, Holcomb JB, Wade CE, Bulger EM, Tilley BC; PROPPR Study Group. Earlier Endpoints are Required for Hemorrhagic Shock Trials Among Severely Injured Patients. Shock. 2017 May;47(5):567-573. doi: 10.1097/SHK.0000000000000788.
Results Reference
background
PubMed Identifier
25823522
Citation
Novak DJ, Bai Y, Cooke RK, Marques MB, Fontaine MJ, Gottschall JL, Carey PM, Scanlan RM, Fiebig EW, Shulman IA, Nelson JM, Flax S, Duncan V, Daniel-Johnson JA, Callum JL, Holcomb JB, Fox EE, Baraniuk S, Tilley BC, Schreiber MA, Inaba K, Rizoli S, Podbielski JM, Cotton BA, Hess JR; PROPPR Study Group. Making thawed universal donor plasma available rapidly for massively bleeding trauma patients: experience from the Pragmatic, Randomized Optimal Platelets and Plasma Ratios (PROPPR) trial. Transfusion. 2015 Jun;55(6):1331-9. doi: 10.1111/trf.13098. Epub 2015 Mar 30.
Results Reference
background
PubMed Identifier
22943967
Citation
Daban JL, Kerleguer A, Clavier B, Salliol A, Ausset S. [Fresh whole blood transfusion for war surgery: the experience of the Kabul French combat support hospital from 2006 to 2009]. Ann Fr Anesth Reanim. 2012 Nov;31(11):850-6. doi: 10.1016/j.annfar.2012.07.014. Epub 2012 Sep 1. French.
Results Reference
background
PubMed Identifier
23953835
Citation
Esnault P, Cungi PJ, Romanat PE, D'Aranda E, Cotte J, Bordes J, Vichard A, Aguillon P, Sailliol A, Meaudre E. [Blood transfusion on battlefield. The Kabul hospital experience]. Ann Fr Anesth Reanim. 2013 Oct;32(10):670-5. doi: 10.1016/j.annfar.2013.06.007. Epub 2013 Aug 13. French.
Results Reference
background
PubMed Identifier
19577407
Citation
Ausset S, Meaudre E, Kaiser E, Sailliol A, Hugard L, Jeandel P. [Acute traumatic haemorrhagic shock and transfusion: the French army policy]. Ann Fr Anesth Reanim. 2009 Jul-Aug;28(7-8):707-9. doi: 10.1016/j.annfar.2009.05.011. Epub 2009 Jul 3. No abstract available. French.
Results Reference
background
PubMed Identifier
17208567
Citation
McGuigan R, Spinella PC, Beekley A, Sebesta J, Perkins J, Grathwohl K, Azarow K. Pediatric trauma: experience of a combat support hospital in Iraq. J Pediatr Surg. 2007 Jan;42(1):207-10. doi: 10.1016/j.jpedsurg.2006.09.020.
Results Reference
background
PubMed Identifier
21051263
Citation
Sailliol A, Clavier B, Cap A, Ausset S. [French European military haemovigilance guidelines]. Transfus Clin Biol. 2010 Dec;17(5-6):315-7. doi: 10.1016/j.tracli.2010.09.001. Epub 2010 Nov 3. French.
Results Reference
background
PubMed Identifier
25159368
Citation
Nair PM, Pidcoke HF, Cap AP, Ramasubramanian AK. Effect of cold storage on shear-induced platelet aggregation and clot strength. J Trauma Acute Care Surg. 2014 Sep;77(3 Suppl 2):S88-93. doi: 10.1097/TA.0000000000000327.
Results Reference
background
PubMed Identifier
24662779
Citation
Pidcoke HF, Spinella PC, Ramasubramanian AK, Strandenes G, Hervig T, Ness PM, Cap AP. Refrigerated platelets for the treatment of acute bleeding: a review of the literature and reexamination of current standards. Shock. 2014 May;41 Suppl 1:51-3. doi: 10.1097/SHK.0000000000000078.
Results Reference
background
PubMed Identifier
28580719
Citation
Nair PM, Pandya SG, Dallo SF, Reddoch KM, Montgomery RK, Pidcoke HF, Cap AP, Ramasubramanian AK. Platelets stored at 4 degrees C contribute to superior clot properties compared to current standard-of-care through fibrin-crosslinking. Br J Haematol. 2017 Jul;178(1):119-129. doi: 10.1111/bjh.14751. Epub 2017 Jun 4.
Results Reference
background
PubMed Identifier
27357229
Citation
Bahr MP, Yazer MH, Triulzi DJ, Collins RA. Whole blood for the acutely haemorrhaging civilian trauma patient: a novel idea or rediscovery? Transfus Med. 2016 Dec;26(6):406-414. doi: 10.1111/tme.12329. Epub 2016 Jun 29.
Results Reference
background
PubMed Identifier
23979267
Citation
Cotton BA, Podbielski J, Camp E, Welch T, del Junco D, Bai Y, Hobbs R, Scroggins J, Hartwell B, Kozar RA, Wade CE, Holcomb JB; Early Whole Blood Investigators. A randomized controlled pilot trial of modified whole blood versus component therapy in severely injured patients requiring large volume transfusions. Ann Surg. 2013 Oct;258(4):527-32; discussion 532-3. doi: 10.1097/SLA.0b013e3182a4ffa0. Erratum In: Ann Surg. 2014 Jul;260(1):178.
Results Reference
background
PubMed Identifier
24662783
Citation
Jenkins D, Stubbs J, Williams S, Berns K, Zielinski M, Strandenes G, Zietlow S. Implementation and execution of civilian remote damage control resuscitation programs. Shock. 2014 May;41 Suppl 1:84-9. doi: 10.1097/SHK.0000000000000133.
Results Reference
background
PubMed Identifier
27100754
Citation
Stubbs JR, Zielinski MD, Jenkins D. The state of the science of whole blood: lessons learned at Mayo Clinic. Transfusion. 2016 Apr;56 Suppl 2(Suppl 2):S173-81. doi: 10.1111/trf.13501.
Results Reference
background
PubMed Identifier
27120323
Citation
Yazer MH, Jackson B, Sperry JL, Alarcon L, Triulzi DJ, Murdock AD. Initial safety and feasibility of cold-stored uncrossmatched whole blood transfusion in civilian trauma patients. J Trauma Acute Care Surg. 2016 Jul;81(1):21-6. doi: 10.1097/TA.0000000000001100.
Results Reference
background
PubMed Identifier
27730689
Citation
Seheult JN, Triulzi DJ, Alarcon LH, Sperry JL, Murdock A, Yazer MH. Measurement of haemolysis markers following transfusion of uncrossmatched, low-titre, group O+ whole blood in civilian trauma patients: initial experience at a level 1 trauma centre. Transfus Med. 2017 Feb;27(1):30-35. doi: 10.1111/tme.12372. Epub 2016 Oct 12.
Results Reference
background
PubMed Identifier
28930957
Citation
Savage SA, Zarzaur BL, Pohlman TH, Brewer BL, Magnotti LJ, Croce MA, Lim GH, Martin AC. Clot dynamics and mortality: The MA-R ratio. J Trauma Acute Care Surg. 2017 Oct;83(4):628-634. doi: 10.1097/TA.0000000000001637.
Results Reference
background
PubMed Identifier
27805995
Citation
Einersen PM, Moore EE, Chapman MP, Moore HB, Gonzalez E, Silliman CC, Banerjee A, Sauaia A. Rapid thrombelastography thresholds for goal-directed resuscitation of patients at risk for massive transfusion. J Trauma Acute Care Surg. 2017 Jan;82(1):114-119. doi: 10.1097/TA.0000000000001270.
Results Reference
background
PubMed Identifier
26720428
Citation
Gonzalez E, Moore EE, Moore HB, Chapman MP, Chin TL, Ghasabyan A, Wohlauer MV, Barnett CC, Bensard DD, Biffl WL, Burlew CC, Johnson JL, Pieracci FM, Jurkovich GJ, Banerjee A, Silliman CC, Sauaia A. Goal-directed Hemostatic Resuscitation of Trauma-induced Coagulopathy: A Pragmatic Randomized Clinical Trial Comparing a Viscoelastic Assay to Conventional Coagulation Assays. Ann Surg. 2016 Jun;263(6):1051-9. doi: 10.1097/SLA.0000000000001608.
Results Reference
background
PubMed Identifier
29411044
Citation
Ince C, Boerma EC, Cecconi M, De Backer D, Shapiro NI, Duranteau J, Pinsky MR, Artigas A, Teboul JL, Reiss IKM, Aldecoa C, Hutchings SD, Donati A, Maggiorini M, Taccone FS, Hernandez G, Payen D, Tibboel D, Martin DS, Zarbock A, Monnet X, Dubin A, Bakker J, Vincent JL, Scheeren TWL; Cardiovascular Dynamics Section of the ESICM. Second consensus on the assessment of sublingual microcirculation in critically ill patients: results from a task force of the European Society of Intensive Care Medicine. Intensive Care Med. 2018 Mar;44(3):281-299. doi: 10.1007/s00134-018-5070-7. Epub 2018 Feb 6.
Results Reference
background
PubMed Identifier
24561562
Citation
Tachon G, Harrois A, Tanaka S, Kato H, Huet O, Pottecher J, Vicaut E, Duranteau J. Microcirculatory alterations in traumatic hemorrhagic shock. Crit Care Med. 2014 Jun;42(6):1433-41. doi: 10.1097/CCM.0000000000000223.
Results Reference
background
PubMed Identifier
27635767
Citation
Tanaka S, Escudier E, Hamada S, Harrois A, Leblanc PE, Vicaut E, Duranteau J. Effect of RBC Transfusion on Sublingual Microcirculation in Hemorrhagic Shock Patients: A Pilot Study. Crit Care Med. 2017 Feb;45(2):e154-e160. doi: 10.1097/CCM.0000000000002064.
Results Reference
background
PubMed Identifier
26542952
Citation
Tanaka S, Harrois A, Nicolai C, Flores M, Hamada S, Vicaut E, Duranteau J. Qualitative real-time analysis by nurses of sublingual microcirculation in intensive care unit: the MICRONURSE study. Crit Care. 2015 Nov 6;19:388. doi: 10.1186/s13054-015-1106-3.
Results Reference
background
PubMed Identifier
24697251
Citation
Zatta AJ, McQuilten ZK, Mitra B, Roxby DJ, Sinha R, Whitehead S, Dunkley S, Kelleher S, Hurn C, Cameron PA, Isbister JP, Wood EM, Phillips LE; Massive Transfusion Registry Steering Committee. Elucidating the clinical characteristics of patients captured using different definitions of massive transfusion. Vox Sang. 2014 Jul;107(1):60-70. doi: 10.1111/vox.12121. Epub 2014 Apr 2.
Results Reference
background
PubMed Identifier
23587620
Citation
Godier A, Samama CM, Susen S. [Management of massive bleeding in 2013: seven questions and answers]. Transfus Clin Biol. 2013 May;20(2):55-8. doi: 10.1016/j.tracli.2013.02.015. Epub 2013 Apr 12. French.
Results Reference
background
PubMed Identifier
29728151
Citation
Hamada SR, Rosa A, Gauss T, Desclefs JP, Raux M, Harrois A, Follin A, Cook F, Boutonnet M; Traumabase(R) Group; Attias A, Ausset S, Boutonnet M, Dhonneur G, Duranteau J, Langeron O, Paugam-Burtz C, Pirracchio R, de St Maurice G, Vigue B, Rouquette A, Duranteau J. Development and validation of a pre-hospital "Red Flag" alert for activation of intra-hospital haemorrhage control response in blunt trauma. Crit Care. 2018 May 5;22(1):113. doi: 10.1186/s13054-018-2026-9.
Results Reference
background
PubMed Identifier
19204506
Citation
Nunez TC, Voskresensky IV, Dossett LA, Shinall R, Dutton WD, Cotton BA. Early prediction of massive transfusion in trauma: simple as ABC (assessment of blood consumption)? J Trauma. 2009 Feb;66(2):346-52. doi: 10.1097/TA.0b013e3181961c35.
Results Reference
background
PubMed Identifier
25682314
Citation
Pommerening MJ, Goodman MD, Holcomb JB, Wade CE, Fox EE, Del Junco DJ, Brasel KJ, Bulger EM, Cohen MJ, Alarcon LH, Schreiber MA, Myers JG, Phelan HA, Muskat P, Rahbar M, Cotton BA; MPH on behalf of the PROMMTT Study Group. Clinical gestalt and the prediction of massive transfusion after trauma. Injury. 2015 May;46(5):807-13. doi: 10.1016/j.injury.2014.12.026. Epub 2015 Feb 4.
Results Reference
background
PubMed Identifier
31625172
Citation
Yazer MH, Delaney M, Doughty H, Dunbar NM, Al-Riyami AZ, Triulzi DJ, Watchko JF, Wood EM, Yahalom V, Emery SP. It is time to reconsider the risks of transfusing RhD negative females of childbearing potential with RhD positive red blood cells in bleeding emergencies. Transfusion. 2019 Dec;59(12):3794-3799. doi: 10.1111/trf.15569. Epub 2019 Oct 18. No abstract available.
Results Reference
background
PubMed Identifier
22739764
Citation
Martinaud C, Civadier C, Ausset S, Verret C, Deshayes AV, Sailliol A. In vitro hemostatic properties of French lyophilized plasma. Anesthesiology. 2012 Aug;117(2):339-46. doi: 10.1097/ALN.0b013e3182608cdd.
Results Reference
background
PubMed Identifier
28059838
Citation
Raux M, Le Manach Y, Gauss T, Baumgarten R, Hamada S, Harrois A, Riou B, Duranteau J, Langeron O, Mantz J, Paugam-Burtz C, Vigue B; TRAUMABASE Group. Comparison of the Prognostic Significance of Initial Blood Lactate and Base Deficit in Trauma Patients. Anesthesiology. 2017 Mar;126(3):522-533. doi: 10.1097/ALN.0000000000001490.
Results Reference
background
PubMed Identifier
23168430
Citation
Regnier MA, Raux M, Le Manach Y, Asencio Y, Gaillard J, Devilliers C, Langeron O, Riou B. Prognostic significance of blood lactate and lactate clearance in trauma patients. Anesthesiology. 2012 Dec;117(6):1276-88. doi: 10.1097/ALN.0b013e318273349d.
Results Reference
background
PubMed Identifier
7575797
Citation
Manikis P, Jankowski S, Zhang H, Kahn RJ, Vincent JL. Correlation of serial blood lactate levels to organ failure and mortality after trauma. Am J Emerg Med. 1995 Nov;13(6):619-22. doi: 10.1016/0735-6757(95)90043-8.
Results Reference
background
PubMed Identifier
8411283
Citation
Abramson D, Scalea TM, Hitchcock R, Trooskin SZ, Henry SM, Greenspan J. Lactate clearance and survival following injury. J Trauma. 1993 Oct;35(4):584-8; discussion 588-9. doi: 10.1097/00005373-199310000-00014.
Results Reference
background
PubMed Identifier
29193548
Citation
Smith IM, Crombie N, Bishop JR, McLaughlin A, Naumann DN, Herbert M, Hancox JM, Slinn G, Ives N, Grant M, Perkins GD, Doughty H, Midwinter MJ; RePHILL Trial Collaborators. RePHILL: protocol for a randomised controlled trial of pre-hospital blood product resuscitation for trauma. Transfus Med. 2018 Oct;28(5):346-356. doi: 10.1111/tme.12486. Epub 2017 Nov 28.
Results Reference
background
PubMed Identifier
29538226
Citation
Boutonnet M, Abback P, Le Sache F, Harrois A, Follin A, Imbert N, Cap AP, Trichereau J, Ausset S; Traumabase Group. Tranexamic acid in severe trauma patients managed in a mature trauma care system. J Trauma Acute Care Surg. 2018 Jun;84(6S Suppl 1):S54-S62. doi: 10.1097/TA.0000000000001880.
Results Reference
background
Citation
Riou B, Thicoïpe M, Atain-Kouadio P, Carli P. Comment evaluer la gravité? In: France S de, editor. Actualités en réanimation préhospitalière, Paris: Société française d'éditions médicales; 2002.
Results Reference
background
Citation
Duranteau J, Asehnoune K, Pierre S, Ozier Y, Leone M, Lefrant J-Y. Recommandations sur la réanimation du choc hémorragique. Anesthésie & Réanimation 2015;1:62-74. https://doi.org/10.1016/j.anrea.2014.12.007.
Results Reference
background
Citation
Massive transfusion in trauma guidelines. American College of Surgeons. Quality improvement project: trauma resuscitation best practice guidelines. Chicago (IL): American College of Surgeons 2013.
Results Reference
background
PubMed Identifier
19417598
Citation
Miller RD. Massive blood transfusions: the impact of Vietnam military data on modern civilian transfusion medicine. Anesthesiology. 2009 Jun;110(6):1412-6. doi: 10.1097/ALN.0b013e3181a1fd54.
Results Reference
background
Citation
Brohi K, Levy H, Boffard K, Riou B, Kiepert P, Zielske D. Normalization of lactate within 8 hours or ≥20% clearance in initial 2 hours correlates with outcomes from traumatic hemorrhagic shock. Critical Care Medicine 2011;39:177.
Results Reference
background
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Evaluation of a Transfusion Therapy Using Whole Blood in the Management of Coagulopathy in Patients With Acute Traumatic Hemorrhage
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