NCT05507983

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2021

Typical duration for phase_3

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 19, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

March 13, 2024

Status Verified

March 1, 2024

Enrollment Period

3.1 years

First QC Date

August 16, 2022

Last Update Submit

March 12, 2024

Conditions

BurnsBlood Loss, SurgicalBlood LossTranexamic AcidBurn Excisional Surgery

Keywords

Blood lossTranexamic AcidBurn excisional surgeryBurns

Outcome Measures

Primary Outcomes (1)

  • Blood loss

    Volume of blood loss measured during surgery.

    During burn excisional surgery

Secondary Outcomes (9)

  • Hospital Mortality

    During total admittance of the patient

  • Length of stay in days

    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

    During burn excisional surgery

  • Cardiopulmonary complications

    Within the first 30 days after burn excisional surgery

  • Neurologic complications

    Within the first 30 days after burn excisional surgery

  • +4 more secondary outcomes

Study Arms (2)

Tranexamic acid arm

EXPERIMENTAL

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

Placebo arm

PLACEBO COMPARATOR

100ml sodium chloride 0.9%, once, directly after anesthetizing the participant.

Drug: Placebo

Interventions

Tranexamic acidDRUG

Tranexamic acid 1500 mg

Tranexamic acid arm
PlaceboDRUG

Placebo, sodium chloride 0.9%

Placebo arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Diffuse intravascular coagulation (based on the diffuse intranasal coagulation-score \>5)
  • Pregnancy
  • Active breastfeeding
  • History of epilepsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Red Cross Hospital

Beverwijk, North Holland, 1940 EB, Netherlands

NOT YET RECRUITING

Maasstad Hospital

Rotterdam, South Holland, 3079 DZ, Netherlands

RECRUITING

Martini Hospital

Groningen, 9728 NT, Netherlands

NOT YET RECRUITING

Related Publications (1)

  • Gigengack RK, Slob J, Vries AM, Bosma E, Loer SA, Koopman JSHA, van der Vlies CH. Efficacy of tranexamic acid versus placebo in reducing blood loss during burn excisional surgery: a multi-center, double-blind, parallel, randomized placebo-controlled clinical trial (TRANEX). Trials. 2024 Aug 2;25(1):520. doi: 10.1186/s13063-024-08332-1.

    PMID: 39095919DERIVED

MeSH Terms

Conditions

BurnsBlood Loss, SurgicalHemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Wounds and InjuriesPathologic ProcessesPathological Conditions, Signs and SymptomsIntraoperative Complications

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Central Study Contacts

C.H. van der Vlies, MD, PhD

CONTACT

010 - 2911911vliesc@maasstadziekenhuis.nl

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2022

First Posted

August 19, 2022

Study Start

December 1, 2021

Primary Completion

January 1, 2025

Study Completion

April 1, 2025

Last Updated

March 13, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

NL(3)