Tranexamic Acid for Reduction of Transfusion in Abdominal Surgery
Recruiting
Phase 3
Interventional Study
Surgical Blood Loss
Transfusion-dependent Anemia
Abdomen Disease
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 850 (estimated)
- Sponsor
- Ulrich Ronellenfitsch, MD · Other
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About This Trial
The goal of this clinical trial is to learn if the administration of tranexamic acid can reduce the necessity of blood transfusions in adult patients undergoing major abdominal surgery. . It will also inform about safety of tranexamic acid in this setting.
The main question it aims to answer is: Does tranexamic acid lower the probability of receiving at least one blood transfusion during or after…
Trial Locations
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Eligibility Criteria
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. Nega…
Contacts