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| Name | Class |
|---|---|
| Société Française d'Anesthésie et de Réanimation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic Acid | Experimental | Patient will receive:
|
|
| Placebo | Placebo Comparator | Patient will receive:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Blood loss (mL / cm² excised) | To determine the impact of tranexamic acid on blood loss in burn surgeries | Until day 5 post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Need for transfusion | Number of blood product transfused | Until day 5 post surgery |
| All-cause Hospital Mortality | Any death during hospital stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mathieu Fontaine, MD, PhD | Saint Joseph Saint Luc Hospital, Burn Intensive Care Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de réanimation des brûlés de Mercy (CHR Metz-Thionville) | Ars-Laquenexy | France | ||||
| Centre Commun de Traitement des Brûlés - Hôpital Edouard Herriot |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 9010613 | 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. | |
| 22611164 |
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| ID | Term |
|---|---|
| D002056 | Burns |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Drug |
0.9% sodium chloride to mimic tranexamic acid |
|
|
| Until day 15 post surgery |
| Success of skin graft | Number of successful skin graft (medical assessment) | Until day 15 post surgery |
| Deep vein thrombosis | Number of deep vein thrombosis | Until day 15 post surgery |
| Myocardial infarction | Number of myocardial infarctions | Until day 15 post surgery |
| Stroke | Number of strokes | Until day 15 post surgery |
| Pulmonary embolism | Number of pulmonary embolisms | Until day 15 post surgery |
| Convulsion | Number of convulsions | Until day 15 post surgery |
| Lyon |
| 69437 |
| France |
| Centre Hospitalier Saint Joseph Saint Luc | Lyon | France |
| Centre des brûlés inter-régional Méditerranée - Hôpital de la Conception | Marseille | France |
| Background |
| 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. |
| 17065899 | Background | 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. |
| 20554319 | Background | 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. |
| 2357138 | Background | 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. |
| 21367529 | Background | 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. |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |