NCT03113253

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2016

Longer than P75 for phase_4

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 22, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 13, 2017

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2021

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2021

Completed
Last Updated

April 4, 2024

Status Verified

April 1, 2024

Enrollment Period

5.1 years

First QC Date

April 10, 2017

Last Update Submit

April 3, 2024

Conditions

Tranexamic AcidBurnsSurgeryWounds and Injuries

Keywords

Tranexamic AcidBurnSurgeryExcision

Outcome Measures

Primary Outcomes (1)

  • Blood loss (mL / cm² excised)

    To determine the impact of tranexamic acid on blood loss in burn surgeries

    Until day 5 post surgery

Secondary Outcomes (8)

  • Need for transfusion

    Until day 5 post surgery

  • All-cause Hospital Mortality

    Until day 15 post surgery

  • Success of skin graft

    Until day 15 post surgery

  • Deep vein thrombosis

    Until day 15 post surgery

  • Myocardial infarction

    Until day 15 post surgery

  • +3 more secondary outcomes

Study Arms (2)

Tranexamic Acid

EXPERIMENTAL

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

Drug: Tranexamic Acid

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Tranexamic AcidDRUG
Also known as: Exacyl
Tranexamic Acid
PlaceboDRUG

0.9% sodium chloride to mimic tranexamic acid

Also known as: 0.9% sodium chloride
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Service de réanimation des brûlés de Mercy (CHR Metz-Thionville)

Ars-Laquenexy, France

Location

Centre Commun de Traitement des Brûlés - Hôpital Edouard Herriot

Lyon, 69437, France

Location

Centre Hospitalier Saint Joseph Saint Luc

Lyon, France

Location

Centre des brûlés inter-régional Méditerranée - Hôpital de la Conception

Marseille, France

Location

Related Publications (8)

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 9010613BACKGROUND

  • 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.

    PMID: 22611164BACKGROUND

  • 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.

    PMID: 17065899BACKGROUND

  • 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.

    PMID: 20554319BACKGROUND

  • 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.

    PMID: 2357138BACKGROUND

  • 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.

    PMID: 21367529BACKGROUND

MeSH Terms

Conditions

BurnsWounds and Injuries

Interventions

Tranexamic AcidSodium Chloride

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Mathieu Fontaine, MD, PhD

    Saint Joseph Saint Luc Hospital, Burn Intensive Care Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2017

First Posted

April 13, 2017

Study Start

September 22, 2016

Primary Completion

November 2, 2021

Study Completion

November 13, 2021

Last Updated

April 4, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(4)