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TRANexamic Acid to Reduce Bleeding in BURN Surgery (TRANBURN)

Primary Purpose

Tranexamic Acid, Burns, Surgery

Status
Active
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Tranexamic Acid
Placebo
Sponsored by
Centre Hospitalier Saint Joseph Saint Luc de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tranexamic Acid focused on measuring Tranexamic Acid, Burn, Surgery, Excision

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects undergoing burn excision surgery for standard of care purposes
  • Male or female >= 18 years of age
  • Subject or subject's medical decision maker agrees to participate in this study and provides informed consent

Exclusion Criteria:

  • Subjects with a history of hypercoagulopathy, deep vein thrombosis (DVT), pulmonary embolism
  • Renal impairment
  • Subjects with known hypersensitivity to tranexamic acid
  • Consecutive fibrinolytic states to coagulopathy
  • History of convulsions

Sites / Locations

  • Service de réanimation des brûlés de Mercy (CHR Metz-Thionville)
  • Centre Commun de Traitement des Brûlés - Hôpital Edouard Herriot
  • Centre Hospitalier Saint Joseph Saint Luc
  • Centre des brûlés inter-régional Méditerranée - Hôpital de la Conception

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tranexamic Acid

Placebo

Arm Description

Patient will receive: 1g of tranexamic acid by slow intravenous injection 1g of tranexamic acid by syringe pump during 8 hours

Patient will receive: 10 mL of 0.9% sodium chloride by slow intravenous injection 48 mL of 0.9% sodium chloride by syringe pump during 8 hours

Outcomes

Primary Outcome Measures

Blood loss (mL / cm² excised)
To determine the impact of tranexamic acid on blood loss in burn surgeries

Secondary Outcome Measures

Need for transfusion
Number of blood product transfused
All-cause Hospital Mortality
Any death during hospital stay
Success of skin graft
Number of successful skin graft (medical assessment)
Deep vein thrombosis
Number of deep vein thrombosis
Myocardial infarction
Number of myocardial infarctions
Stroke
Number of strokes
Pulmonary embolism
Number of pulmonary embolisms
Convulsion
Number of convulsions

Full Information

First Posted
April 10, 2017
Last Updated
February 8, 2022
Sponsor
Centre Hospitalier Saint Joseph Saint Luc de Lyon
Collaborators
Société Française d'Anesthésie et de Réanimation
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1. Study Identification

Unique Protocol Identification Number
NCT03113253
Brief Title
TRANexamic Acid to Reduce Bleeding in BURN Surgery
Acronym
TRANBURN
Official Title
The Effect of Tranexamic Acid (TXA) on Blood Loss in Burn Surgery - A Randomized, Double-Blinded Placebo-Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 22, 2016 (Actual)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
March 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Saint Joseph Saint Luc de Lyon
Collaborators
Société Française d'Anesthésie et de Réanimation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Excision and grafting in burn patients can lead to severe blood loss. A preliminary study conducted in Saint Joseph Saint Luc Hospital showed that the total median blood loss was 1412 mL (1). Transfused patients had a total median blood loss of 2468 mL and an average number of 4 packed red blood cells (PRBC) administered. Among the various methods that help limit blood loss, tranexamic acid, which has been proved useful in traumatology and surgery, has not been sufficiently studied in burn patients. A preliminary study in 27 burned patients showed a reduction of blood loss with tranexamic acid (2). Objective of TRANBURN study is to demonstrate that tranexamic acid help limit blood loss and reduces the use of blood products.
Detailed Description
The first aim of the study is to demonstrate that tranexamic acid help limit blood loss and reduces the use of blood products. Secondary objectives are to evaluate impact of tranexamic acid on mortality, success of skin grafts and occurrence of deep vein thrombosis or myocardial infarction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tranexamic Acid, Burns, Surgery, Wounds and Injuries
Keywords
Tranexamic Acid, Burn, Surgery, Excision

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tranexamic Acid
Arm Type
Experimental
Arm Description
Patient will receive: 1g of tranexamic acid by slow intravenous injection 1g of tranexamic acid by syringe pump during 8 hours
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patient will receive: 10 mL of 0.9% sodium chloride by slow intravenous injection 48 mL of 0.9% sodium chloride by syringe pump during 8 hours
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Other Intervention Name(s)
Exacyl
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
0.9% sodium chloride
Intervention Description
0.9% sodium chloride to mimic tranexamic acid
Primary Outcome Measure Information:
Title
Blood loss (mL / cm² excised)
Description
To determine the impact of tranexamic acid on blood loss in burn surgeries
Time Frame
Until day 5 post surgery
Secondary Outcome Measure Information:
Title
Need for transfusion
Description
Number of blood product transfused
Time Frame
Until day 5 post surgery
Title
All-cause Hospital Mortality
Description
Any death during hospital stay
Time Frame
Until day 15 post surgery
Title
Success of skin graft
Description
Number of successful skin graft (medical assessment)
Time Frame
Until day 15 post surgery
Title
Deep vein thrombosis
Description
Number of deep vein thrombosis
Time Frame
Until day 15 post surgery
Title
Myocardial infarction
Description
Number of myocardial infarctions
Time Frame
Until day 15 post surgery
Title
Stroke
Description
Number of strokes
Time Frame
Until day 15 post surgery
Title
Pulmonary embolism
Description
Number of pulmonary embolisms
Time Frame
Until day 15 post surgery
Title
Convulsion
Description
Number of convulsions
Time Frame
Until day 15 post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects undergoing burn excision surgery for standard of care purposes Male or female >= 18 years of age Subject or subject's medical decision maker agrees to participate in this study and provides informed consent Exclusion Criteria: Subjects with a history of hypercoagulopathy, deep vein thrombosis (DVT), pulmonary embolism Renal impairment Subjects with known hypersensitivity to tranexamic acid Consecutive fibrinolytic states to coagulopathy History of convulsions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathieu Fontaine, MD, PhD
Organizational Affiliation
Saint Joseph Saint Luc Hospital, Burn Intensive Care Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de réanimation des brûlés de Mercy (CHR Metz-Thionville)
City
Ars-Laquenexy
Country
France
Facility Name
Centre Commun de Traitement des Brûlés - Hôpital Edouard Herriot
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
Centre Hospitalier Saint Joseph Saint Luc
City
Lyon
Country
France
Facility Name
Centre des brûlés inter-régional Méditerranée - Hôpital de la Conception
City
Marseille
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Farny B, Fontaine M, Payre J, Ravat F, Poupelin J-C, Latarjet J. Évaluation des pertes sanguines lors des chirurgies d'excision-autogreffe de peau chez les patients brûlés. Anesthésie & Réanimation. 2015;1:A307-8.
Results Reference
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Citation
Jennes S, Degrave E, Despiegeleer X, Grenez O. Effect of Tranexamic Acid on Blood Loss in Burn Surgery: A Preliminary Study. Journal of Burn Care & Rehabilitation. 2003;24:S59.
Results Reference
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PubMed Identifier
9010613
Citation
Mercuriali F, Inghilleri G. Proposal of an algorithm to help the choice of the best transfusion strategy. Curr Med Res Opin. 1996;13(8):465-78. doi: 10.1185/03007999609115227.
Results Reference
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PubMed Identifier
22611164
Citation
Ker K, Edwards P, Perel P, Shakur H, Roberts I. Effect of tranexamic acid on surgical bleeding: systematic review and cumulative meta-analysis. BMJ. 2012 May 17;344:e3054. doi: 10.1136/bmj.e3054.
Results Reference
background
PubMed Identifier
17065899
Citation
Zufferey P, Merquiol F, Laporte S, Decousus H, Mismetti P, Auboyer C, Samama CM, Molliex S. Do antifibrinolytics reduce allogeneic blood transfusion in orthopedic surgery? Anesthesiology. 2006 Nov;105(5):1034-46. doi: 10.1097/00000542-200611000-00026.
Results Reference
background
PubMed Identifier
20554319
Citation
CRASH-2 trial collaborators; Shakur H, Roberts I, Bautista R, Caballero J, Coats T, Dewan Y, El-Sayed H, Gogichaishvili T, Gupta S, Herrera J, Hunt B, Iribhogbe P, Izurieta M, Khamis H, Komolafe E, Marrero MA, Mejia-Mantilla J, Miranda J, Morales C, Olaomi O, Olldashi F, Perel P, Peto R, Ramana PV, Ravi RR, Yutthakasemsunt S. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010 Jul 3;376(9734):23-32. doi: 10.1016/S0140-6736(10)60835-5. Epub 2010 Jun 14.
Results Reference
background
PubMed Identifier
2357138
Citation
Desai MH, Herndon DN, Broemeling L, Barrow RE, Nichols RJ Jr, Rutan RL. Early burn wound excision significantly reduces blood loss. Ann Surg. 1990 Jun;211(6):753-9; discussion 759-62. doi: 10.1097/00000658-199006000-00015.
Results Reference
background
PubMed Identifier
21367529
Citation
Curinga G, Jain A, Feldman M, Prosciak M, Phillips B, Milner S. Red blood cell transfusion following burn. Burns. 2011 Aug;37(5):742-52. doi: 10.1016/j.burns.2011.01.016. Epub 2011 Mar 1.
Results Reference
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Links:
URL
http://www.ch-stjoseph-stluc-lyon.fr/sp%C3%A9cialit%C3%A9s/4.Recherche%20clinique/
Description
Saint Joseph Saint Luc Hospital

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TRANexamic Acid to Reduce Bleeding in BURN Surgery

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