Tranexamic Acid During Excisional Burn Surgery

Launched by MAASSTAD HOSPITAL · Aug 18, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how effective the drug tranexamic acid is in reducing blood loss during excisional burn surgery. If you have burns that require surgical treatment and your doctor expects that you might lose a significant amount of blood during the procedure, you might be eligible to participate. To qualify, you need to be at least 18 years old, scheduled for surgery, and have a planned burn excision that could lead to at least 250 milliliters of blood loss. It's important that you or your legal representative can understand Dutch to provide informed consent.

If you decide to participate, you will receive tranexamic acid before your surgery. The study aims to see if this medication can help minimize blood loss during your procedure. However, there are certain health conditions that would prevent you from joining, such as having a bleeding disorder, severe kidney issues, or allergies to tranexamic acid. This trial is currently recruiting participants, and your involvement could help improve care for future patients undergoing similar surgeries.

Gender

ALL

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