Clinical trial NCT05507983: Tranexamic Acid During Excisional Burn Surgery
Official title: Tranexamic Acid During Excisional Burn Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Burns
Blood Loss, Surgical
Blood Loss
Tranexamic Acid
Burn Excisional Surgery
Keywords: Blood loss
Tranexamic Acid
Burn excisional surgery
Burns
Lead sponsor: Maasstad Hospital
Sponsor class: OTHER
Collaborators: name: Association of Dutch Burn Centres
name: Martini Hospital Groningen
name: Red Cross Hospital Beverwijk
First posted: 2022-08-19
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to access the efficacy of the drug tranexamic acid in reducing blood loss during burn excision surgery.

Detailed description: 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.

Eligibility 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 / % total body surface area, (2) operation technique used (some techniques show more blood loss than others), (3) time after burn trauma (i.e. expected healing)
* ≥18 year
* informed consent of patient or legal representative
* Patients or legal representative should have enough knowledge of Dutch to provide informed consent

Exclusion Criteria:

* Patients with a recorded coagulopathy in their history
* The use of anticoagulants (except acetylsalicylic acid or (intensive) prophylaxis low molecular weight heparin \>12 hours before surgery)
* Severe kidney failure (creatinine \>500 μmol/L)
* Allergy for tranexamic acid
* Diagnosis of acute venous-/arterial thrombosis within 3 months before inclusion
* Diffuse intravascular coagulation (based on the diffuse intranasal coagulation-score \>5)
* Pregnancy
* Active breastfeeding
* History of epilepsy

Primary outcomes:
measure: Blood loss
timeFrame: During burn excisional surgery
Secondary outcomes:
measure: Hospital Mortality
timeFrame: During total admittance of the patient
measure: Length of stay in days
timeFrame: 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.
measure: Graft failure in % of total graft
timeFrame: During burn excisional surgery
measure: Cardiopulmonary complications
timeFrame: Within the first 30 days after burn excisional surgery
measure: Neurologic complications
timeFrame: Within the first 30 days after burn excisional surgery
measure: The need for escape medication
timeFrame: During burn excisional surgery
measure: Extend of fibrinolysis during burn excisional surgery
timeFrame: During burn excisional surgery
measure: Strength of blood clot
timeFrame: During burn excisional surgery
measure: Transfusion requirements
timeFrame: Perioperative, within the first day after surgery.
Other outcomes:
Locations:
city: Beverwijk
country: Netherlands
facility: Red Cross Hospital
state: Noord-Holland
city: Rotterdam
country: Netherlands
facility: Maasstad Hospital
state: Zuid-Holland
city: Groningen
country: Netherlands
facility: Martini Hospital
Study officials:
References: