Tranexamic acid during excisional burn surgery

Recruiting

• Conditions: Coagulation; fibrinolysis; 10064477

• Registration Number: NL-OMON55963
• Lead Sponsor: Maasstadziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 95

Inclusion Criteria

- Patients scheduled for burn excisional surgery
- An expected blood loss of >=250ml based on the estimation by the performing
surgeon on the basis of: (1) 2 % body surface area excision planned (100-200 cc
/ %TBSA, based on retrospective data from Burn Centre Rotterdam), (2) operation
technique used (some techniques show more blood loss than others), (3) time
after burn trauma (i.e. expected healing).
- >=18 years

Exclusion Criteria

- Patients with a recorded coagulopathy in their history
- Severe kidney failure (creatinine >500 umol/L)
- Allergy for tranexamic acid
- Acute venous-/arterial thrombosis (ongoing thrombosis). A history of
thrombosis is NOT an exclusion criterion
- Diffuse intravascular coagulation
- Pregnancy
- History of epilepsy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoints are the volume of blood loss and the extend of<br /><br>fibrinolysis. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Blood transfusion requirements:<br /><br>- Number of blood product transfused<br /><br>Hospital Mortality<br /><br>Length of stay<br /><br>Operation success:<br /><br>- Success of skin graft (percentage successful take)<br /><br>Cardiopulmonary complication (i.e. arterial embolism)<br /><br>Neurologic complications (i.e. stroke, conclusion)<br /><br>Strength of the blood cloth and fibrin-structures</p><br>