Tranexamic Acid During Excisional Burn Surgery (TRANEX)

Maasstad Hospital

Status and phase: Enrolling; Phase 3

Conditions: Tranexamic Acid; Blood Loss, Surgical; Burn Excisional Surgery; Burns; Blood Loss

Treatments: Drug: Tranexamic acid; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05507983

NL69319.100.20

WO 19.102 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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96 participants in 2 patient groups, including a placebo group

Tranexamic acid arm

Experimental group

Description:

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.

Treatment:

Drug: Tranexamic acid

Placebo arm

Placebo Comparator group

Description:

100ml sodium chloride 0.9%, once, directly after anesthetizing the participant.

Treatment:

Drug: Placebo