Tranexamic Acid During Excisional Burn Surgery (TRANEX)

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

Study Overview

• Status: Recruiting
• Conditions: Burns; Blood Loss; Blood Loss, Surgical; Tranexamic Acid; Burn Excisional Surgery
• Intervention / Treatment: Drug: Tranexamic acid; Drug: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: C.H. van der Vlies, MD, PhD; Phone Number: 010 - 2911911; Email: vliesc@maasstadziekenhuis.nl

Study Locations

• Netherlands
  • Groningen, Netherlands, 9728 NT
    • Not yet recruiting
    • Martini Hospital
    • Contact: S.M.H.J. Scholten-Jaegers; Phone Number: 050 - 524 52 45; Email: s.scholten@mzh.nl
  • Noord-Holland
    • Beverwijk, Noord-Holland, Netherlands, 1940 EB
      • Not yet recruiting
      • Red Cross Hospital
      • Contact: A. de Vries, MD, PhD; Phone Number: 0251-265555; Email: adevries@rkz.nl
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands, 3079 DZ
      • Recruiting
      • Maasstad Hospital
      • Contact: C.H. van der Vlies; Phone Number: 010-2911911; Email: vliesc@maasstadziekenhuis.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tranexamic acid arm; Tranexamic acid 1500 mg dissolved in 100 ml sodium chloride, once, directly after anesthetizing the participant. In participants with renal insufficiency (creatinine >120 umol/L) the dose will be reduced to 1000 mg.	Drug: Tranexamic acid; Tranexamic acid 1500 mg
Placebo Comparator: Placebo arm; 100ml sodium chloride 0.9%, once, directly after anesthetizing the participant.	Drug: Placebo; Placebo, sodium chloride 0.9%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood loss	Volume of blood loss measured during surgery.	During burn excisional surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Mortality	% of mortality in patients participating in this study.	During total admittance of the patient
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.
Graft failure in % of total graft	% of graft failure of the total graft.	During burn excisional surgery
Cardiopulmonary complications	i.e. pulmonary embolism, arterial embolism.	Within the first 30 days after burn excisional surgery
Neurologic complications	i.e. stroke of epilepsy	Within the first 30 days after burn excisional surgery
The need for escape medication	Out of protocol administration of tranexamic acid based on massive blood loss.	During burn excisional surgery
Extend of fibrinolysis during burn excisional surgery	Measured by ROTEM analysis	During burn excisional surgery
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
Transfusion requirements	Number of transfusions in the perioperative phase.	Perioperative, within the first day after surgery.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: August 16, 2022
• First Submitted That Met QC Criteria: August 18, 2022
• First Posted (Actual): August 19, 2022

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Burns; Tranexamic Acid; Blood loss; Burn excisional surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Intraoperative Complications; Burns; Hemorrhage; Blood Loss, Surgical; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: NL69319.100.20; WO 19.102 (Other Grant/Funding Number: Dutch Burn Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No