Tranexamic Acid for Reduction of Transfusion in Abdominal Surgery

Launched by ULRICH RONELLENFITSCH, MD · May 10, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called tranexamic acid can help reduce the need for blood transfusions in adults undergoing major abdominal surgeries, such as stomach or bowel surgeries. The main question is: Does taking tranexamic acid lower the chances of needing a blood transfusion during or after the surgery? Participants will receive either tranexamic acid or a placebo, which looks like the medicine but doesn’t contain any active ingredients, to see if the drug is effective in reducing blood loss.

To be eligible for this study, participants need to be 18 years or older and have planned elective surgery on their abdomen. They should also have good kidney function and be able to give written consent to join the trial. It’s important to note that people with certain conditions, such as severe anemia or specific bleeding disorders, will not be included in the study. Those who participate can expect to be closely monitored during their surgery and recovery to assess the safety and effectiveness of tranexamic acid. This trial is currently recruiting participants, and both men and women are welcome to join.

Gender

ALL

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. 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