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| ID | Type | Description | Link |
|---|---|---|---|
| WO 19.102 | Other Grant/Funding Number | Dutch Burn Foundation |
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| Name | Class |
|---|---|
| Association of Dutch Burn Centres | OTHER |
| Martini Hospital Groningen | OTHER |
| Red Cross Hospital Beverwijk | OTHER |
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The purpose of this study is to access the efficacy of the drug tranexamic acid in reducing blood loss during burn excision surgery.
This study is a double-blinded, randomized placebo-controlled trial. After informed consent patients will be randomized in either the placebo or the tranexamic acid group (1500 mg). The intervention will be conducted during burn excisional surgery. First, the participant with be anesthetized, whereafter the study medication is administered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic acid arm | Experimental | Tranexamic acid 1500 mg dissolved in 100 ml sodium chloride, once, directly after anesthetizing the participant. In participants with renal insufficiency (creatinine >120 umol/L) the dose will be reduced to 1000 mg. |
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| Placebo arm | Placebo Comparator | 100ml sodium chloride 0.9%, once, directly after anesthetizing the participant. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid | Drug | Tranexamic acid 1500 mg |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Blood loss | Volume of blood loss measured during surgery. | During burn excisional surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Mortality | % of mortality in patients participating in this study. | During total admittance of the patient |
| Length of stay in days | Number of days admitted after burn trauma. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| C.H. van der Vlies, MD, PhD | Contact | 010 - 2911911 | vliesc@maasstadziekenhuis.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Red Cross Hospital | Not yet recruiting | Beverwijk | North Holland | 1940 EB | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39095919 | Derived | Gigengack RK, Slob J, Vries AM, Bosma E, Loer SA, Koopman JSHA, van der Vlies CH. Efficacy of tranexamic acid versus placebo in reducing blood loss during burn excisional surgery: a multi-center, double-blind, parallel, randomized placebo-controlled clinical trial (TRANEX). Trials. 2024 Aug 2;25(1):520. doi: 10.1186/s13063-024-08332-1. |
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| ID | Term |
|---|---|
| D002056 | Burns |
| D016063 | Blood Loss, Surgical |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Drug |
Placebo, sodium chloride 0.9% |
|
| The length of stay will be evaluated after 3 months after inclusion. If, after 3 months, the patient is still admitted, the status of hospitalisation will be check after an addition 3 months. |
| Graft failure in % of total graft | % of graft failure of the total graft. | During burn excisional surgery |
| Cardiopulmonary complications | i.e. pulmonary embolism, arterial embolism. | Within the first 30 days after burn excisional surgery |
| Neurologic complications | i.e. stroke of epilepsy | Within the first 30 days after burn excisional surgery |
| The need for escape medication | Out of protocol administration of tranexamic acid based on massive blood loss. | During burn excisional surgery |
| Extend of fibrinolysis during burn excisional surgery | Measured by ROTEM analysis | During burn excisional surgery |
| Strength of blood clot | Analysis will be performed using (electron) microscope to investigate: strength, thickness, structure of fibrin, fibrin clot networks and cell disposition within the blood clot. | During burn excisional surgery |
| Transfusion requirements | Number of transfusions in the perioperative phase. | Perioperative, within the first day after surgery. |
| Maasstad Hospital | Recruiting | Rotterdam | South Holland | 3079 DZ | Netherlands |
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| Martini Hospital | Not yet recruiting | Groningen | 9728 NT | Netherlands |
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