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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03113253
Other study ID # TRANBURN
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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