Tranexamic Acid for Reduction of Transfusion in Abdominal Surgery

Surgical Blood Loss Clinical Trial

— TATRA  

Official title:

Tranexamic Acid for Reduction of Intra- and Postoperative Transfusion Requirements in Elective Abdominal Surgery: Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06414031
• Other study ID #: TATRA
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 1, 2024
• Est. completion date: November 30, 2025

Study information

• Verified date: May 2024
• Source: Martin-Luther-Universität Halle-Wittenberg
• Contact: Ulrich Ronellenfitsch, MD
• Phone: +493455572327
• Email: ulrich.ronellenfitsch[@]uk-halle.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 850
• Est. completion date: November 30, 2025
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdomen Disease
• Blood Loss, Surgical
• Surgical Blood Loss
• Transfusion-dependent Anemia

Intervention

Drug:
• Tranexamic Acid
Intravenous administration
• Placebo
Intravenous administration

Locations

Country	Name	City	State
Germany	University Hospital, Dpt. of Abdominal, Vascular and Endocrine Surgery	Halle (Saale)

Sponsors (3)

Lead Sponsor	Collaborator
Ulrich Ronellenfitsch, MD	Coordinating Centre for Clinical Trials Halle, German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transfusion necessity	Intra- or postoperative transfusion of at least one unit of packed red blood cells	Until hospital discharge or 30 days postoperatively, whatever occurs earlier
Secondary	Transfusion amount	Number of transfused units of packed red blood cells per patient	Until hospital discharge or 30 days postoperatively, whatever occurs earlier
Secondary	Blood loss	Estimated intraoperative blood loss	From skin incision to suture
Secondary	Postoperative complications and mortality	Postoperative complications and mortality assessed according to the Clavien-Dindo scheme	Until hospital discharge or 30 days postoperatively, whatever occurs earlier
Secondary	Length of hospital stay	Time period from hospital admission to discharge	From hospital admission to discharge
Secondary	Operation time	Time period from skin incision to suture	From skin incision to suture
Secondary	Anesthesia time	Time period from anesthesia induction to end of anesthesia	From anesthesia induction to end of anesthesia
Secondary	D-dimer levels	Serum levels of D-dimers	Until hospital discharge or 30 days postoperatively, whatever occurs earlier
Secondary	Adverse events	Any adverse event attributed to the intervention comprising anaphylaxis, thromboembolic events, acute renal failure, acute heart failure, seizures	Until hospital discharge or 30 days postoperatively, whatever occurs earlier