Surgery Clinical Trial
— TRANBURNOfficial title:
The Effect of Tranexamic Acid (TXA) on Blood Loss in Burn Surgery - A Randomized, Double-Blinded Placebo-Controlled Trial
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 |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Saint Joseph Saint Luc de Lyon | Société Française d'Anesthésie et de Réanimation |
France,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05583916 -
Same Day Discharge for Video-Assisted Thoracoscopic Surgery (VATS) Lung Surgery
|
N/A | |
Completed |
NCT04448041 -
CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
|
||
Completed |
NCT03213314 -
HepaT1ca: Quantifying Liver Health in Surgical Candidates for Liver Malignancies
|
N/A | |
Enrolling by invitation |
NCT05534490 -
Surgery and Functionality in Older Adults
|
N/A | |
Recruiting |
NCT04792983 -
Cognition and the Immunology of Postoperative Outcomes
|
||
Terminated |
NCT04612491 -
Pre-operative Consultation on Patient Anxiety and First-time Mohs Micrographic Surgery
|
||
Recruiting |
NCT06397287 -
PROM Project Urology
|
||
Recruiting |
NCT04444544 -
Quality of Life and High-Risk Abdominal Cancer Surgery
|
||
Completed |
NCT04204785 -
Noise in the OR at Induction: Patient and Anesthesiologists Perceptions
|
N/A | |
Completed |
NCT03432429 -
Real Time Tissue Characterisation Using Mass Spectrometry REI-EXCISE iKnife Study
|
||
Completed |
NCT04176822 -
Designing Animated Movie for Preoperative Period
|
N/A | |
Recruiting |
NCT05370404 -
Prescribing vs. Recommending Over-The-Counter (PROTECT) Analgesics for Patients With Postoperative Pain:
|
N/A | |
Not yet recruiting |
NCT05467319 -
Ferric Derisomaltose/Iron Isomaltoside and Outcomes in the Recovery of Gynecologic Oncology ERAS
|
Phase 3 | |
Recruiting |
NCT04602429 -
Children's Acute Surgical Abdomen Programme
|
||
Completed |
NCT03124901 -
Accuracy of Noninvasive Pulse Oximeter Measurement of Hemoglobin for Rainbow DCI Sensor
|
N/A | |
Completed |
NCT04595695 -
The Effect of Clear Masks in Improving Patient Relationships
|
N/A | |
Recruiting |
NCT06103136 -
Maestro 1.0 Post-Market Registry
|
||
Completed |
NCT05346588 -
THRIVE Feasibility Trial
|
Phase 3 | |
Completed |
NCT04059328 -
Novel Surgical Checklists for Gynecologic Laparoscopy in Haiti
|
||
Recruiting |
NCT03697278 -
Monitoring Postoperative Patient-controlled Analgesia (PCA)
|
N/A |