Using tranexamic acid to reduce blood transfusions in abdominal surgery
Tranexamic Acid for Reduction of Intra- and Postoperative Transfusion Requirements in Elective Abdominal Surgery: Randomized Controlled Trial
This study is testing if giving tranexamic acid to adults having major abdominal surgeries can help reduce the need for blood transfusions.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 850 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Martin-Luther-Universität Halle-Wittenberg Academic / other |
| Locations | 2 sites (Dresden, Saxony and 1 other locations) |
| Trial ID | NCT06414031 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether tranexamic acid can decrease the need for blood transfusions in adult patients undergoing major abdominal surgeries such as esophagectomy, gastrectomy, and colectomy. Participants will be randomly assigned to receive either tranexamic acid or a placebo, allowing researchers to compare the effectiveness of the drug against a non-active treatment. The study also aims to assess the safety of tranexamic acid in this surgical context. By focusing on patients with planned elective surgeries, the trial seeks to provide valuable insights into managing surgical blood loss.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are scheduled for elective major abdominal surgeries.
Not a fit: Patients who are not undergoing major abdominal surgery or those with contraindications to tranexamic acid will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the need for blood transfusions during major abdominal surgeries, improving patient outcomes and safety.
How similar studies have performed: Previous studies have shown promising results with tranexamic acid in reducing blood loss in various surgical settings, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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. 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
Where this trial is running
Dresden, Saxony and 1 other locations
- University Hospital Carl Gustav Carus Dresden — Dresden, Saxony, Germany (Recruiting)
- University Hospital, Dpt. of Abdominal, Vascular and Endocrine Surgery — Halle, Germany (Recruiting)
Study contacts
- Principal investigator: Ulrich Ronellenfitsch, MD — Medical Faculty of the Martin Luther University Halle-Wittenberg
- Study coordinator: Ulrich Ronellenfitsch, MD
- Email: ulrich.ronellenfitsch@uk-halle.de
- Phone: +493455572327
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.