Tranexamic Acid During Excisional Burn Surgery

• Status: Recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maasstad Hospital
• Collaborators: Association of Dutch Burn Centres; Martini Hospital Groningen; Red Cross Hospital Beverwijk
• Treatments: Tranexamic Acid

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