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CompletedNCT03113253TRANBURNUpdated Apr 4, 2024

TRANexamic Acid to Reduce Bleeding in BURN Surgery

A Phase 4 interventional study of Tranexamic Acid and Placebo in Tranexamic Acid, Burns and Surgery, sponsored by Centre Hospitalier Saint Joseph Saint Luc de Lyon. Completed at 4 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-04.

Sponsored by Centre Hospitalier Saint Joseph Saint Luc de Lyon · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Sep 2016, registered Apr 2017).
Phase
Phase 4
Study type
Interventional
Enrollment
121
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Tranexamic Acid
  • Burns
  • Surgery
  • Wounds and Injuries

Keywords

  • Tranexamic Acid
  • Burn
  • Surgery
  • Excision
03

In context

Burns

730 studies on the registry are indexed under Burns; 146 are open to participants now.

This study's enrollment of 121 is above the median of 40 across 534 interventional studies indexed under Burns.

Browse Burns studies →

Lead sponsor

Centre Hospitalier Saint Joseph Saint Luc de Lyon is the lead sponsor of 22 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
121 participants (actual)

Study arms

  • Experimental
    Tranexamic Acid

    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 comparator
    Placebo

    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

  • DrugTranexamic Acid

    Also known as: Exacyl

  • DrugPlacebo

    0.9% sodium chloride to mimic tranexamic acid

    Also known as: 0.9% sodium chloride

06

What researchers measure

Primary outcomes

  1. Blood loss (mL / cm² excised)

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

    Time frame: Until day 5 post surgery

Secondary outcomes

  1. Need for transfusion

    Number of blood product transfused

    Time frame: Until day 5 post surgery

  2. All-cause Hospital Mortality

    Any death during hospital stay

    Time frame: Until day 15 post surgery

  3. Success of skin graft

    Number of successful skin graft (medical assessment)

    Time frame: Until day 15 post surgery

  4. Deep vein thrombosis

    Number of deep vein thrombosis

    Time frame: Until day 15 post surgery

  5. Myocardial infarction

    Number of myocardial infarctions

    Time frame: Until day 15 post surgery

  6. Stroke

    Number of strokes

    Time frame: Until day 15 post surgery

  7. Pulmonary embolism

    Number of pulmonary embolisms

    Time frame: Until day 15 post surgery

  8. Convulsion

    Number of convulsions

    Time frame: Until day 15 post surgery

07

Study locations

4 sites
  • Service de réanimation des brûlés de Mercy (CHR Metz-Thionville)
    Ars-Laquenexy, France
  • Centre Commun de Traitement des Brûlés - Hôpital Edouard Herriot
    Lyon, 69437, France
  • Centre Hospitalier Saint Joseph Saint Luc
    Lyon, France
  • Centre des brûlés inter-régional Méditerranée - Hôpital de la Conception
    Marseille, France
08

References and documents

Publications

  • 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.
  • 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.
  • 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. PubMed 9010613 ↗
  • 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. PubMed 22611164 ↗
  • 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. PubMed 17065899 ↗
  • 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. PubMed 20554319 ↗
  • 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. PubMed 2357138 ↗
  • 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. PubMed 21367529 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2016 to primary completion in Nov 2021, 61 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 10, 2017
First posted
Apr 13, 2017
StartActual
Sep 22, 2016
Primary completionActual
Nov 2, 2021
CompletionActual
Nov 13, 2021
Last update
Apr 4, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03113253
Lead sponsor
Centre Hospitalier Saint Joseph Saint Luc de Lyon
Collaborators
Société Française d'Anesthésie et de Réanimation
Responsible party
Sponsor
First posted
Apr 13, 2017
Start date
Sep 22, 2016
Primary completion
Nov 2, 2021
Completion
Nov 13, 2021
Last update
Apr 4, 2024

Study contacts

Mathieu Fontaine, MD, PhD
principal investigator · Saint Joseph Saint Luc Hospital, Burn Intensive Care Unit

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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