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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
96
Tranexamic acid 1500 mg
Placebo, sodium chloride 0.9%
Red Cross Hospital
Beverwijk, North Holland, Netherlands
NOT_YET_RECRUITINGMaasstad Hospital
Rotterdam, South Holland, Netherlands
RECRUITINGMartini Hospital
Groningen, Netherlands
NOT_YET_RECRUITINGBlood 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
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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.