Tranexamic Acid for Reduction of Transfusion in Abdominal Surgery (TATRA)

Ulrich Ronellenfitsch, MD

Status and phase: Enrolling; Phase 3

Conditions: Surgical Blood Loss; Transfusion-dependent Anemia; Abdomen Disease

Treatments: Drug: Tranexamic Acid; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06414031

TATRA

2023-509970-43-01 (EU Trial (CTIS) Number)

01KG2305 (Other Grant/Funding Number)

Details and patient eligibility

About

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 surgery?

Participants will compare tranexamic acid o a placebo (a look-alike substance that contains no drug) to see if tranexamic acid works to reduce the necessity of a blood transfusion.

Enrollment: 850 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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850 participants in 2 patient groups, including a placebo group

Tranexamic acid

Experimental group

Description:

Intravenous administration of tranexamic acid (1 g bolus 10 minutes prior to skin incision followed by continuous infusion 125 mg / hour until skin closure)

Treatment:

Drug: Tranexamic Acid

Placebo

Placebo Comparator group

Description:

Intravenous administration of placebo (normal saline), 50 ml bolus 10 minutes prior to skin incision followed by continuous infusion of 6.25 ml / hour until skin closure.

Treatment:

Drug: Placebo