A Phase 3 interventional study of Tranexamic acid and Placebo in Burns, Blood Loss, Surgical and Blood Loss, sponsored by Maasstad Hospital. Recruiting at 3 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-13.
Sponsored by Maasstad Hospital · Phase 3, Interventional, and Treatment
Among 22 studies in Burns with a site in Netherlands — 3 open to participants now, 5 under way, 2 of them phase 3. Burns · Netherlands.
Among the 22 studies in Burns with a site in Netherlands, this one is the 5th largest by planned enrollment of the 17 interventional ones, is one of 2 that started in 2021, is one of 8 in phase 3, and was the 20th registered.
905 studies on the registry are indexed under Burns; 164 are open to participants now.
This study's planned enrollment of 96 is above the median of 40 across 663 interventional studies indexed under Burns.
Browse Burns studies →3 of the 22 studies in Burns with a site in Netherlands are open now, in 9 countries. Each count lists the studies.
Of the 84 Burns studies recruiting now, 38 (45%) set no upper age limit and 37 (44%) stop at 75 or younger; 17 take children under 18; 9 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →22 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 2 started in 2021.
Median enrollment 40 across the 17 interventional studies, 98 across the 4 observational. Of the 17 that completed or were terminated, 1 (6%) have results posted.
5 of 22 have an industry lead sponsor. The 9 most frequent:
Maasstad Hospital is the lead sponsor of 21 studies on the registry; 5 are open to participants now.
Maasstad Hospital has 3 studies filed under Burns — fewer than ten, so there is no comparison to draw.
1 of the studies in Burns with a site in Netherlands that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06745557Phase 3CUTISS AGPhase III Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Adults and Adolescents | 2027-06-30 |
Among the 22 studies in Burns with a site in Netherlands, from their registry updates:
Nothing recorded among them since 2026-09-25.
The purpose of this study is to access the efficacy of the drug tranexamic acid in reducing blood loss during burn excision surgery.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
100ml sodium chloride 0.9%, once, directly after anesthetizing the participant.
Drug: Placebo
Tranexamic acid 1500 mg
Placebo, sodium chloride 0.9%
Blood loss
Volume of blood loss measured during surgery.
Time frame: During burn excisional surgery
Hospital Mortality
% of mortality in patients participating in this study.
Time frame: During total admittance of the patient
Length of stay in days
Number of days admitted after burn trauma.
Time frame: 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.
Time frame: During burn excisional surgery
Cardiopulmonary complications
i.e. pulmonary embolism, arterial embolism.
Time frame: Within the first 30 days after burn excisional surgery
Neurologic complications
i.e. stroke of epilepsy
Time frame: 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.
Time frame: During burn excisional surgery
Extend of fibrinolysis during burn excisional surgery
Measured by ROTEM analysis
Time frame: 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.
Time frame: During burn excisional surgery
Transfusion requirements
Number of transfusions in the perioperative phase.
Time frame: Perioperative, within the first day after surgery.
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2021 (actual). Primary completion is estimated for Jan 2025, 37 months after the start.
Of 21 phase 3 interventional studies under Burns, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 59. This study's planned 37 months is above that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Tranexamic Acid
Maasstad Hospital