TRANexamic Acid to Reduce Bleeding in BURN Surgery (TRANBURN)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03113253|
Recruitment Status : Unknown
Verified April 2017 by Centre Hospitalier Saint Joseph Saint Luc de Lyon.
Recruitment status was: Recruiting
First Posted : April 13, 2017
Last Update Posted : April 13, 2017
Excision and grafting in burn patients can lead to severe blood loss. A preliminary study conducted in our burn unit 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.
|Condition or disease||Intervention/treatment||Phase|
|Tranexamic Acid Burns Surgery Wounds and Injuries||Drug: Tranexamic Acid Drug: Placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||102 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Effect of Tranexamic Acid (TXA) on Blood Loss in Burn Surgery - A Randomized, Double-Blinded Placebo-Controlled Trial|
|Actual Study Start Date :||September 22, 2016|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||January 2018|
Experimental: Tranexamic Acid
Patient will receive:
Drug: Tranexamic Acid
Other Name: Exacyl
Placebo Comparator: Placebo
Patient will receive:
0.9% sodium chloride to mimic tranexamic acid
Other Name: 0.9% sodium chloride
- Blood loss (mL / cm² excised) [ Time Frame: Until day 5 post surgery ]To determine the impact of tranexamic acid on blood loss in burn surgeries
- Need for transfusion [ Time Frame: Until day 5 post surgery ]Number of blood product transfused
- All-cause Hospital Mortality [ Time Frame: Until day 15 post surgery ]Any death during hospital stay
- Success of skin graft [ Time Frame: Until day 15 post surgery ]Number of successful skin graft
- Deep vein thrombosis [ Time Frame: Until day 15 post surgery ]Number of deep vein thrombosis
- Myocardial infarction [ Time Frame: Until day 15 post surgery ]Number of myocardial infarctions
- Stroke [ Time Frame: Until day 15 post surgery ]
- Pulmonary embolism [ Time Frame: Until day 15 post surgery ]
- Convulsion [ Time Frame: Until day 15 post surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03113253
|Contact: Mathieu Fontainefirstname.lastname@example.org|
|Centre Commun de Traitement des Brûlés - Hôpital Edouard Herriot||Not yet recruiting|
|Lyon, France, 69437|
|Contact: Thomas Rimmelé, MD, PhD +33472116988 email@example.com|
|Centre Hospitalier Saint Joseph Saint Luc||Recruiting|
|Contact: Stéphane Rio +33478618216 firstname.lastname@example.org|
|Principal Investigator: Mathieu Fontaine, MD, PhD|
|Sub-Investigator: François Ravat, MD|
|Sub-Investigator: Jacques Latarjet, MD|
|Sub-Investigator: Delphine Voulliaume, MD|
|Sub-Investigator: Jacqueline Payre, MD|
|Sub-Investigator: Jean-Charles Poupelin, MD|
|Principal Investigator:||Mathieu Fontaine, MD, PhD||Saint Joseph Saint Luc Hospital, Burn Intensive Care Unit|