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TRANEX

Phase 1
Recruiting
Conditions
Burn injury
Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]
Registration Number
CTIS2024-513573-49-00
Lead Sponsor
Maasstad Ziekenhuis Stichting
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
95
Inclusion Criteria

1. Patients scheduled for burn excisional surgery 2. 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 year

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 clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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