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BurnsPhase 3TRANEXNCT05507983

Tranexamic Acid During Excisional Burn Surgery

A Phase 3 study testing Tranexamic acid in people with Burns and Blood Loss, Surgical, run by Maasstad Hospital at 3 sites in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Burns, Blood Loss, Surgical, Blood Loss
What is being tested?
Tranexamic acid
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
96 participants
Where
3 sitesNetherlands
Study dates
1 Dec 2021to 1 Apr 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 9Show fewer
  • Pregnancy
  • Active breastfeeding
  • History of epilepsy

Trial locations and contacts

3 sites in 1 country.

C.H. van der Vlies, MD, PhD contact

010 - 2911911

vliesc@maasstadziekenhuis.nl

Netherlands3 sites, 3 recruiting

  • Red Cross Hospital

    Beverwijk, North Holland, 1940 EB

    A. de Vries, MD, PhD, 0251-265555, adevries@rkz.nl

    Not yet recruiting

  • Martini Hospital

    Groningen, 9728 NT

    S.M.H.J. Scholten-Jaegers, 050 - 524 52 45, s.scholten@mzh.nl

    Not yet recruiting

  • Maasstad Hospital

    Rotterdam, South Holland, 3079 DZ

    C.H. van der Vlies, 010-2911911, vliesc@maasstadziekenhuis.nl

    Recruiting

Other trials in Netherlands

About this study

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

Read the 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.

Being tested
Tranexamic acid, Placebo
Keywords
Blood loss, Tranexamic Acid, Burn excisional surgery, Burns
Medical subject headings
Burns, Blood Loss, Surgical, Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tranexamic acidDrug

    Tranexamic acid 1500 mg

  • PlaceboDrug

    Placebo, sodium chloride 0.9%

Study groups in NCT05507983
Study groupRoleWhat they receive
Tranexamic acid armExperimentalTranexamic 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.
Receives: Drug: Tranexamic acid
Placebo armPlacebo comparator100ml sodium chloride 0.9%, once, directly after anesthetizing the participant.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood loss

    Volume of blood loss measured during surgery.

    Measured: During burn excisional surgery

Secondary outcomes (9)

  1. Hospital Mortality

    % of mortality in patients participating in this study.

    Measured: During total admittance of the patient

  2. Length of stay in days

    Number of days admitted after burn trauma.

    Measured: 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.

  3. Graft failure in % of total graft

    % of graft failure of the total graft.

    Measured: During burn excisional surgery

  4. Cardiopulmonary complications

    i.e. pulmonary embolism, arterial embolism.

    Measured: Within the first 30 days after burn excisional surgery

  5. Neurologic complications

    i.e. stroke of epilepsy

    Measured: Within the first 30 days after burn excisional surgery

  6. The need for escape medication

    Out of protocol administration of tranexamic acid based on massive blood loss.

    Measured: During burn excisional surgery

  7. Extend of fibrinolysis during burn excisional surgery

    Measured by ROTEM analysis

    Measured: During burn excisional surgery

  8. 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.

    Measured: During burn excisional surgery

  9. Transfusion requirements

    Number of transfusions in the perioperative phase.

    Measured: Perioperative, within the first day after surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2022
  2. Study start1 Dec 2021
  3. Primary completion1 Jan 2025 (estimated)
  4. Study completion1 Apr 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
96 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05507983
Sponsor's protocol ID
NL69319.100.20
Other IDs
WO 19.102
Acronym
TRANEX
Status last verified
Mar 2024
First submitted
16 Aug 2022
Last updated
13 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39095919

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tranexamic acid in people with Burns and Blood Loss, Surgical, run by Maasstad Hospital at 3 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact C.H. van der Vlies, MD, PhD (010 - 2911911, vliesc@maasstadziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood loss (time frame: During burn excisional surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05507983, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.

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