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Tranexamic acid during excisional burn surgery

Tranexamic acid during excisional burn surgery - TRANEX

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON55963
Enrollment
95
Registered
2021-02-22
Start date
2021-12-06
Completion date
Unknown
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coagulation fibrinolysis

Interventions

After induction of anesthesia, but before incision, study medication will be administered. The intervention group will receive 2000mg tranexamic acid. The placebo group will receive a NaCl 0.9% bolu

Sponsors

Maasstadziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
The main study endpoints are the volume of blood loss and the extend of fibrinolysis.

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)