TRANexamic Acid to Reduce Bleeding in BURN Surgery

Surgery Clinical Trial

— TRANBURN  

Official title:

The Effect of Tranexamic Acid (TXA) on Blood Loss in Burn Surgery - A Randomized, Double-Blinded Placebo-Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03113253
• Other study ID #: TRANBURN
• Status: Completed
• Phase: Phase 4
• Start date: September 22, 2016
• Est. completion date: November 13, 2021

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Saint Joseph Saint Luc de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: November 13, 2021
• Est. primary completion date: November 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burns
• Surgery
• Tranexamic Acid
• Wounds and Injuries

Intervention

Drug:
• Tranexamic Acid

• Placebo
0.9% sodium chloride to mimic tranexamic acid

Locations

Country	Name	City	State
France	Service de réanimation des brûlés de Mercy (CHR Metz-Thionville)	Ars-Laquenexy
France	Centre Commun de Traitement des Brûlés - Hôpital Edouard Herriot	Lyon
France	Centre Hospitalier Saint Joseph Saint Luc	Lyon
France	Centre des brûlés inter-régional Méditerranée - Hôpital de la Conception	Marseille

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Saint Joseph Saint Luc de Lyon	Société Française d'Anesthésie et de Réanimation

Country where clinical trial is conducted

France, 

References & Publications (8)

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. — View 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. — View 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. — View 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.

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.

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood loss (mL / cm² excised)	To determine the impact of tranexamic acid on blood loss in burn surgeries	Until day 5 post surgery
Secondary	Need for transfusion	Number of blood product transfused	Until day 5 post surgery
Secondary	All-cause Hospital Mortality	Any death during hospital stay	Until day 15 post surgery
Secondary	Success of skin graft	Number of successful skin graft (medical assessment)	Until day 15 post surgery
Secondary	Deep vein thrombosis	Number of deep vein thrombosis	Until day 15 post surgery
Secondary	Myocardial infarction	Number of myocardial infarctions	Until day 15 post surgery
Secondary	Stroke	Number of strokes	Until day 15 post surgery
Secondary	Pulmonary embolism	Number of pulmonary embolisms	Until day 15 post surgery
Secondary	Convulsion	Number of convulsions	Until day 15 post surgery

External Links

•   Saint Joseph Saint Luc Hospital