Clinical trial NCT03113253: TRANexamic Acid to Reduce Bleeding in BURN Surgery
Official title: The Effect of Tranexamic Acid (TXA) on Blood Loss in Burn Surgery - A Randomized, Double-Blinded Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tranexamic Acid
Burns
Surgery
Wounds and Injuries
Keywords: Tranexamic Acid
Burn
Surgery
Excision
Lead sponsor: Centre Hospitalier Saint Joseph Saint Luc de Lyon
Sponsor class: OTHER
Collaborators: name: Société Française d'Anesthésie et de Réanimation
First posted: 2017-04-13
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Blood loss (mL / cm² excised)
timeFrame: Until day 5 post surgery
Secondary outcomes:
measure: Need for transfusion
timeFrame: Until day 5 post surgery
measure: All-cause Hospital Mortality
timeFrame: Until day 15 post surgery
measure: Success of skin graft
timeFrame: Until day 15 post surgery
measure: Deep vein thrombosis
timeFrame: Until day 15 post surgery
measure: Myocardial infarction
timeFrame: Until day 15 post surgery
measure: Stroke
timeFrame: Until day 15 post surgery
measure: Pulmonary embolism
timeFrame: Until day 15 post surgery
measure: Convulsion
timeFrame: Until day 15 post surgery
Other outcomes:
Locations:
city: Ars-Laquenexy
country: France
facility: Service de réanimation des brûlés de Mercy (CHR Metz-Thionville)
city: Lyon
country: France
facility: Centre Commun de Traitement des Brûlés - Hôpital Edouard Herriot
city: Lyon
country: France
facility: Centre Hospitalier Saint Joseph Saint Luc
city: Marseille
country: France
facility: Centre des brûlés inter-régional Méditerranée - Hôpital de la Conception
Study officials:
affiliation: Saint Joseph Saint Luc Hospital, Burn Intensive Care Unit
name: Mathieu Fontaine, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.