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Tranexamic Acid During Excisional Burn Surgery

Tranexamic Acid During Excisional Burn Surgery

Recruiting
18 years and older
All
Phase 3

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Overview

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

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

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

Study details
    Burns
    Blood Loss
    Surgical
    Blood Loss
    Tranexamic Acid
    Burn Excisional Surgery

NCT05507983

Maasstad Hospital

20 March 2024

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