Blood-Saving drug tested in 850-Person surgery trial
NCT ID NCT06414031
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether tranexamic acid, a drug that helps blood clot, can lower the chance of needing a blood transfusion during or after major abdominal surgery. About 850 adults having planned surgeries like stomach or liver removal will receive either the drug or a placebo. The goal is to see if the drug safely reduces transfusion needs.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 850 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2024
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 18 years or above 2. Planned elective esophagectomy, gastrectomy, colectomy, rectal resection, pancreatic resection, or hepatectomy 3. Adequate renal function with serum creatinine \<250 µmol/L (2.82 mg/dL) 4. Written informed consent obtained before randomization 5. Negative pregnancy test for women of childbearing potential within 14 days of commencing study treatment. Females of reproductive potential must agree to practice highly effective contraceptive measures during the study. These comprise measures with a failure rate of \<1% per year when used consistently and correctly, such as intravaginal and transdermal combined (oestrogen and progestogen containing) hormonal contraception, injectable and implantable progestogen-only hormonal contraception, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion; vasectomised partner, sexual abstinence (defined as refraining from heterosexual intercourse during the entire study period). Exclusion Criteria: 1. Severe anaemia, defined as a haemoglobin concentration \<8 g/dL (\<5 mmol/L) or anaemia with haemoglobin concentration ≥8 to \<10 g/dL (≥5,0 to \<6,2 mmol/l) and one or several of the following symptoms suggesting hypoxemia: * Clinical signs of tachycardia, e.g., resting heart rate \>100 beats/minute, palpitation etc. * Clinical signs of hypotension, e.g., resting systolic blood pressure \<100 mmHg, orthostatic dysregulation etc. * Clinical signs of dyspnea, e.g., speech dyspnea, resting respiratory rate \>20 breaths/min. 2. Thrombocytopenia with platelets \<60 x 109 /L 3. Confirmed bleeding disorder with the need for specific preventive perioperative treatment (e.g., factor deficiency with the need of perioperative substitution) 4. A priori refusal of blood transfusions 5. Confirmed thrombophilia with a pertinent need for perioperative anticoagulation 6. Allergy / hypersensitivity to tranexamic acid 7. Recent (\<30 days) thromboembolic event 8. History of medically confirmed convulsions 9. In female subjects: pregnancy or lactation
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University Hospital Carl Gustav Carus Dresden
RECRUITINGDresden, Saxony, 01307, Germany
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University Hospital, Dpt. of Abdominal, Vascular and Endocrine Surgery
RECRUITINGHalle, 06120, Germany
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