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Tranexamic Acid for reduction of intra- and postoperative TRansfusion requirements in elective Abdominal surgery: randomized controlled trial (TATRA)
EU CTIS ID: 2023-509970-43-01
What this study is testing
The primary objective of this trial is to assess whether intraoperative administration of Tranexamic Acid reduces hemorrhage and thus the need for intra- and postoperative transfusion of packed red blood cells for major abdominal operations.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients ≥18 years
- Planned elective esophagectomy, gastrectomy, colectomy, rectal resection, pancreatic resection, or hepatectomy
- Adequate renal function with serum creatinine <250 μmol/L (2.82 mg/dL)
- Written informed consent obtained before randomization
- Negative pregnancy test for women of childbearing potential within 14 days of com-mencing 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; vasectomised partner, sexual abstinence (defined as refraining from heterosexual intercourse during the entire study period).
- Capability to understand character and individual consequences of trial participation
You likely can't join if
- Severe anaemia (haemoglobin concentration <8 g/dL (<5 mmol/L)) or Anaemia with haemoglobin concentration ≥8 to <10 g/dL (≥5,0 100 beats/minute, palpi-tation 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.
- Thrombocytopenia with platelets <60 x 109 /L
- Confirmed bleeding disorder with the need for specific preventive perioperative treat-ment (e.g., factor deficiency with the need of perioperative substitution)
- A priori refusal of blood transfusions
- Confirmed thrombophilia with a pertinent need for perioperative anticoagulation
- Allergy / hypersensitivity to TXA
See the full eligibility criteria
- Patients ≥18 years
- Planned elective esophagectomy, gastrectomy, colectomy, rectal resection, pancreatic resection, or hepatectomy
- Adequate renal function with serum creatinine <250 μmol/L (2.82 mg/dL)
- Written informed consent obtained before randomization
- Negative pregnancy test for women of childbearing potential within 14 days of com-mencing 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; vasectomised partner, sexual abstinence (defined as refraining from heterosexual intercourse during the entire study period).
- Capability to understand character and individual consequences of trial participation
- Severe anaemia (haemoglobin concentration <8 g/dL (<5 mmol/L)) or Anaemia with haemoglobin concentration ≥8 to <10 g/dL (≥5,0 100 beats/minute, palpi-tation 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.
- Thrombocytopenia with platelets <60 x 109 /L
- Confirmed bleeding disorder with the need for specific preventive perioperative treat-ment (e.g., factor deficiency with the need of perioperative substitution)
- A priori refusal of blood transfusions
- Confirmed thrombophilia with a pertinent need for perioperative anticoagulation
- Allergy / hypersensitivity to TXA
- Recent (<30 days) thromboembolic event
- History of medically confirmed convulsions
- In female subjects: pregnancy or lactation.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.