Tranexamic Acid During Excisional Burn Surgery

Burns Clinical Trial

— TRANEX  

Official title:

Tranexamic Acid During Excisional Burn Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05507983
• Other study ID #: NL69319.100.20
• Secondary ID: WO 19.102
• Status: Recruiting
• Phase: Phase 3
• Start date: December 1, 2021
• Est. completion date: April 1, 2025

Study information

• Verified date: March 2024
• Source: Maasstad Hospital
• Contact: C.H. van der Vlies, MD, PhD
• Phone: 010 - 2911911
• Email: vliesc[@]maasstadziekenhuis.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: April 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Blood Loss
• Blood Loss, Surgical
• Burns
• Hemorrhage
• Tranexamic Acid

Intervention

Drug:
• Tranexamic acid
Tranexamic acid 1500 mg
• Placebo
Placebo, sodium chloride 0.9%

Locations

Country	Name	City	State
Netherlands	Red Cross Hospital	Beverwijk	Noord-Holland
Netherlands	Martini Hospital	Groningen
Netherlands	Maasstad Hospital	Rotterdam	Zuid-Holland

Sponsors (4)

Lead Sponsor	Collaborator
Maasstad Hospital	Association of Dutch Burn Centres, Martini Hospital Groningen, Red Cross Hospital Beverwijk

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood loss	Volume of blood loss measured during surgery.	During burn excisional surgery
Secondary	Hospital Mortality	% of mortality in patients participating in this study.	During total admittance of the patient
Secondary	Length of stay in days	Number of days admitted after burn trauma.	The length of stay will be evaluated after 3 months after inclusion. If, after 3 months, the patient is still admitted, the status of hospitalisation will be check after an addition 3 months.
Secondary	Graft failure in % of total graft	% of graft failure of the total graft.	During burn excisional surgery
Secondary	Cardiopulmonary complications	i.e. pulmonary embolism, arterial embolism.	Within the first 30 days after burn excisional surgery
Secondary	Neurologic complications	i.e. stroke of epilepsy	Within the first 30 days after burn excisional surgery
Secondary	The need for escape medication	Out of protocol administration of tranexamic acid based on massive blood loss.	During burn excisional surgery
Secondary	Extend of fibrinolysis during burn excisional surgery	Measured by ROTEM analysis	During burn excisional surgery
Secondary	Strength of blood clot	Analysis will be performed using (electron) microscope to investigate: strength, thickness, structure of fibrin, fibrin clot networks and cell disposition within the blood clot.	During burn excisional surgery
Secondary	Transfusion requirements	Number of transfusions in the perioperative phase.	Perioperative, within the first day after surgery.