Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
96 participants
INTERVENTIONAL
2021-12-01
2025-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Tranexamic acid
Tranexamic acid 1500 mg
Placebo arm
100ml sodium chloride 0.9%, once, directly after anesthetizing the participant.
Placebo
Placebo, sodium chloride 0.9%
Interventions
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Tranexamic acid
Tranexamic acid 1500 mg
Placebo
Placebo, sodium chloride 0.9%
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Association of Dutch Burn Centres
OTHER
Martini Hospital Groningen
OTHER
Red Cross Hospital Beverwijk
OTHER
Maasstad Hospital
OTHER
Responsible Party
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Locations
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Red Cross Hospital
Beverwijk, North Holland, Netherlands
Maasstad Hospital
Rotterdam, South Holland, Netherlands
Martini Hospital
Groningen, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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WO 19.102
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
NL69319.100.20
Identifier Type: -
Identifier Source: org_study_id
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