Using tranexamic acid to reduce blood loss during burn surgery
Tranexamic Acid During Excisional Burn Surgery
This study is testing if giving tranexamic acid during burn surgery can help reduce blood loss for patients undergoing the procedure.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Maasstad Hospital Academic / other |
| Locations | 3 sites (Beverwijk, Noord-Holland and 2 other locations) |
| Trial ID | NCT05507983 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of tranexamic acid in minimizing blood loss during excisional surgery for burn patients. It is a double-blinded, randomized, placebo-controlled study where participants will receive either tranexamic acid or a placebo during their surgical procedure. Patients scheduled for burn excision surgery with an anticipated blood loss of at least 250ml will be included in the study. The trial aims to determine if tranexamic acid can significantly reduce the amount of blood lost during surgery, thereby improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults scheduled for burn excisional surgery with an expected blood loss of 250ml or more.
Not a fit: Patients with coagulopathy, severe kidney failure, or those on anticoagulants may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce blood loss during burn surgeries, leading to better recovery outcomes for patients.
How similar studies have performed: Other studies have shown promising results with tranexamic acid in reducing blood loss in various surgical settings, suggesting potential success in this context.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beverwijk, Noord-Holland and 2 other locations
- Red Cross Hospital — Beverwijk, Noord-Holland, Netherlands (Not_yet_recruiting)
- Maasstad Hospital — Rotterdam, Zuid-Holland, Netherlands (Recruiting)
- Martini Hospital — Groningen, Netherlands (Not_yet_recruiting)
Study contacts
- Study coordinator: C.H. van der Vlies, MD, PhD
- Email: vliesc@maasstadziekenhuis.nl
- Phone: 010 - 2911911
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.