Evaluating of the Hospital Universitario de Canarias Massive Transfusion Protocol (PHM)
Primary Purpose
Massive Transfusion, Hemorrhage
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Application Protocol
Sponsored by

About this trial
This is an interventional treatment trial for Massive Transfusion
Eligibility Criteria
Inclusion Criteria:
- Patients with massive haemorrhage and surgery
- Informed consent
Exclusion Criteria:
- <18 years old patients
- Patients didn´t want to participate in this study
- Patients were participated in other studies
Sites / Locations
- Complejo Universitario de CanariasRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention (cases)
No Intervention (control))
Arm Description
Intervention: Massive transfusion protocol resuscitation aiming at ratio 1:1:1 of blood components (RBC:FFP:PLT) and conventional coagulation tests guiding further resuscitation with blood products and procoagulant factors
all patients with massive haemorrhage in which the massive transfusion protocol didn´t apply
Outcomes
Primary Outcome Measures
30-day Mortality
Time to Hemostasis
Time to hemostasis refers to the time that the subject achieved hemorrhage control (anatomic hemostasis and resuscitation complete)following emergency department arrival.
Secondary Outcome Measures
Incidence of Massive Transfusion Related Serious Adverse Events
Immunological reactions No immunological reactions
Severity of coagulopathy associated with high transfusion ratios
Amount of Blood Products Given to Hemostasis
Amount of Blood Products Given From Hemostasis to 24 Hours After
Full Information
NCT ID
NCT03074890
First Posted
December 22, 2016
Last Updated
March 5, 2017
Sponsor
Hospital Universitario de Canarias
1. Study Identification
Unique Protocol Identification Number
NCT03074890
Brief Title
Evaluating of the Hospital Universitario de Canarias Massive Transfusion Protocol
Acronym
PHM
Official Title
Observational Study to Assess the Safety and Clinical Effectiveness of the Hospital Universitario de Canarias Massive Transfusion Protocol
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
August 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario de Canarias
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Massive haemorrhage is defined as the necessity of 3 or more packed red blood cells in one hour, the transfusion of 10 packed blood cells, the loss of the half of the blood volume, the loss of 4-5 cc/kg/h or more, and haemorrhage shock.
Haemorrhage shock provokes changes in the bloodstream with celular and organic disfunction. In many cases massive transfusion is needed to stabilize the vital function. This massive transfusion can have serious side effects (infectious and immunologic and no immunologic reactions) and increase the morbidity and mortality.
Massive transfusion protocols improve the survival in severe trauma injury patients. The transfusion of fixed rate of packed red blood cells, fresh frozen plasma and platelet concentrates have decreased the severity of trauma induced coagulopathy.
Recently several studies have shown the benefit of massive transfusion protocols with high transfusion ratios (1:1:1 RBC:FFP:PLT) in mortality after severe trauma. So early and aggressive transfusion improve the outcomes and the resources.
Massive Transfusion Protocol have been elaborated in the Hospital Universitario de Canarias with high transfusion ratios (1:1:1 RBC:FFP:PLT) . The goals of this protocol is to reduce the variability in the clinic experience, to reduce the transfusion necessities and to assure an safe treatment with blood products.
So with this study the investigators will evaluate if the goals of this Protocol are followed and if the use of this Protocol is really safe and efficient.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Massive Transfusion, Hemorrhage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention (cases)
Arm Type
Experimental
Arm Description
Intervention: Massive transfusion protocol resuscitation aiming at ratio 1:1:1 of blood components (RBC:FFP:PLT) and conventional coagulation tests guiding further resuscitation with blood products and procoagulant factors
Arm Title
No Intervention (control))
Arm Type
No Intervention
Arm Description
all patients with massive haemorrhage in which the massive transfusion protocol didn´t apply
Intervention Type
Device
Intervention Name(s)
Application Protocol
Intervention Description
Application lMassive Transfusion Protocol
Primary Outcome Measure Information:
Title
30-day Mortality
Time Frame
First 30 day after massive transfusion
Title
Time to Hemostasis
Description
Time to hemostasis refers to the time that the subject achieved hemorrhage control (anatomic hemostasis and resuscitation complete)following emergency department arrival.
Time Frame
admission to hospital discharge or 30 days, whichever comes first
Secondary Outcome Measure Information:
Title
Incidence of Massive Transfusion Related Serious Adverse Events
Description
Immunological reactions No immunological reactions
Time Frame
30 days
Title
Severity of coagulopathy associated with high transfusion ratios
Time Frame
30 days post admission
Title
Amount of Blood Products Given to Hemostasis
Time Frame
24 hours from randomization
Title
Amount of Blood Products Given From Hemostasis to 24 Hours After
Time Frame
24 hours after admission
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with massive haemorrhage and surgery
Informed consent
Exclusion Criteria:
<18 years old patients
Patients didn´t want to participate in this study
Patients were participated in other studies
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vanesa González Fariña, MD
Email
vanefari@outlook.com
First Name & Middle Initial & Last Name or Official Title & Degree
María Martín Lorenzo, MD
Email
mcmartín-lorenzo@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vanesa González Fariña, MD
Organizational Affiliation
Hospital Universitario de Canarias
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Juan J Jiménez Rivera, MD
Organizational Affiliation
Hospital Universitario de Canarias
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
José M Raya Sánchez, MD
Organizational Affiliation
Hospital Universitario de Canarias
Official's Role
Study Director
Facility Information:
Facility Name
Complejo Universitario de Canarias
City
La Laguna del Marquesado
State/Province
Santa Cruz de Tenerife
ZIP/Postal Code
38320
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magali Gonzaàlez- Colaço Harmand, MD,PhD
Phone
34922678115
Email
magaligch@hotmail.com
First Name & Middle Initial & Last Name & Degree
Ana Aldea, MD, PhD
Phone
34922678115
Email
a.aldea@gmail.com
First Name & Middle Initial & Last Name & Degree
Vanesa González Fariña, MD
First Name & Middle Initial & Last Name & Degree
María Martín Lorenzo, MD
First Name & Middle Initial & Last Name & Degree
Nuria Montón Giménez, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
17298665
Citation
Spahn DR, Cerny V, Coats TJ, Duranteau J, Fernandez-Mondejar E, Gordini G, Stahel PF, Hunt BJ, Komadina R, Neugebauer E, Ozier Y, Riddez L, Schultz A, Vincent JL, Rossaint R; Task Force for Advanced Bleeding Care in Trauma. Management of bleeding following major trauma: a European guideline. Crit Care. 2007;11(1):R17. doi: 10.1186/cc5686. Erratum In: Crit Care. 2007 Apr 24;11(2):414.
Results Reference
background
PubMed Identifier
16763487
Citation
Malone DL, Hess JR, Fingerhut A. Massive transfusion practices around the globe and a suggestion for a common massive transfusion protocol. J Trauma. 2006 Jun;60(6 Suppl):S91-6. doi: 10.1097/01.ta.0000199549.80731.e6.
Results Reference
background
PubMed Identifier
18090009
Citation
Borgman MA, Spinella PC, Perkins JG, Grathwohl KW, Repine T, Beekley AC, Sebesta J, Jenkins D, Wade CE, Holcomb JB. The ratio of blood products transfused affects mortality in patients receiving massive transfusions at a combat support hospital. J Trauma. 2007 Oct;63(4):805-13. doi: 10.1097/TA.0b013e3181271ba3.
Results Reference
background
PubMed Identifier
23789799
Citation
Leal-Noval SR, Munoz M, Asuero M, Contreras E, Garcia-Erce JA, Llau JV, Moral V, Paramo JA, Quintana M; Spanish Society of Anaesthesiology and Reanimation (SEDAR); Spanish Society of Haematology and Haemotherapy (SEHH); Spanish Society of Hospital Pharmacy (SEFH); Spanish Society of Intensive Care, Critical and Coronary Units (SEMICYUC); Spanish Society of Thrombosis and Haemostasis (SETH); Spanish Society of Blood Transfusion (SETS). [2013: The Seville document on consensus on the alternatives to allogenic blood transfusion. Update to the Seville document. Spanish Societies of Anaesthesiology (SEDAR), Haematology and Haemotherapy (SEHH), Hospital Pharmacy (SEFH), Critical Care Medicine (SEMICYUC), Thrombosis and Haemostasis (SETH) and Blood Transfusion (SETS)]. Farm Hosp. 2013 May-Jun;37(3):209-35. doi: 10.7399/FH.2013.37.3.133. Spanish.
Results Reference
background
PubMed Identifier
19131804
Citation
Cotton BA, Au BK, Nunez TC, Gunter OL, Robertson AM, Young PP. Predefined massive transfusion protocols are associated with a reduction in organ failure and postinjury complications. J Trauma. 2009 Jan;66(1):41-8; discussion 48-9. doi: 10.1097/TA.0b013e31819313bb.
Results Reference
background
Learn more about this trial
Evaluating of the Hospital Universitario de Canarias Massive Transfusion Protocol
We'll reach out to this number within 24 hrs