A Phase 3 interventional study of Tranexamic acid and Placebo in Burns, Blood Loss, Surgical and Blood Loss, sponsored by Maasstad Hospital. Recruiting at 3 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-13.
Sponsored by Maasstad Hospital · Phase 3, Interventional, and Treatment
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.
Exclusion Criteria:
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.
Drug: Tranexamic acid
100ml sodium chloride 0.9%, once, directly after anesthetizing the participant.
Drug: Placebo
Tranexamic acid 1500 mg
Placebo, sodium chloride 0.9%
Blood loss
Volume of blood loss measured during surgery.
Time frame: During burn excisional surgery
Hospital Mortality
% of mortality in patients participating in this study.
Time frame: During total admittance of the patient
Length of stay in days
Number of days admitted after burn trauma.
Time frame: 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.
Time frame: During burn excisional surgery
Cardiopulmonary complications
i.e. pulmonary embolism, arterial embolism.
Time frame: Within the first 30 days after burn excisional surgery
Neurologic complications
i.e. stroke of epilepsy
Time frame: 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.
Time frame: During burn excisional surgery
Extend of fibrinolysis during burn excisional surgery
Measured by ROTEM analysis
Time frame: 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.
Time frame: During burn excisional surgery
Transfusion requirements
Number of transfusions in the perioperative phase.
Time frame: Perioperative, within the first day after surgery.
Plan to share: No
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Maasstad Hospital