Tranexamic Acid for Reduction of Transfusion in Abdominal Surgery

NCT ID: NCT06414031

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 850 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-17
• Study Completion Date: 2025-11-30

Brief 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.

Conditions

Surgical Blood Loss; Transfusion-dependent Anemia; Abdomen Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Tranexamic acid

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

Group Type: EXPERIMENTAL

Tranexamic Acid

Intervention Type: DRUG

Intravenous administration

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Intravenous administration

Interventions

Tranexamic Acid

Intravenous administration

Intervention Type: DRUG

Placebo

Intravenous administration

Intervention Type: DRUG

Other Intervention Names

Tranexamsäure Carinopharm 100mg/ml; Isotone Kochsalz-Lösung 0,9% Infusionslösung

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role: collaborator

Coordinating Centre for Clinical Trials Halle

UNKNOWN

Sponsor Role: collaborator

Ulrich Ronellenfitsch, MD

OTHER

Sponsor Role: lead

Responsible Party

Ulrich Ronellenfitsch, MD

Professor of Evidence-based Abdominal Surgical Oncology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ulrich Ronellenfitsch, MD

Role: PRINCIPAL_INVESTIGATOR

Medical Faculty of the Martin Luther University Halle-Wittenberg

Locations

University Hospital Carl Gustav Carus Dresden

Dresden, Saxony, Germany

Site Status: RECRUITING

University Hospital, Dpt. of Abdominal, Vascular and Endocrine Surgery

Halle, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Ulrich Ronellenfitsch, MD

Role: CONTACT

ulrich.ronellenfitsch@uk-halle.de

+493455572327

Facility Contacts

Olga Radulova-Mauersberger, MD

Role: primary

olga.radulova-mauersberger@ukdd.de

+49 351 458 19543

Ulrich Ronellenfitsch, MD

Role: primary

ulrich.ronellenfitsch@uk-halle.de

+49 345 557 2327

References

Ronellenfitsch U, Kestel A, Klose J, Rebelo A, Bucher M, Ebert D, Mikolajczyk R, Wienke A, Kegel T, Hering J, Haiduk C, Richter M, Steighardt J, Grohmann E, Otto L, Kleeff J. Tranexamic Acid for reduction of intra- and postoperative TRansfusion requirements in elective Abdominal surgery (TATRA): study protocol for an investigator-initiated, multicenter, double-blind, placebo-controlled, randomized superiority trial with two parallel groups. Trials. 2024 Oct 19;25(1):695. doi: 10.1186/s13063-024-08541-8.

Reference Type: DERIVED

PMID: 39425234 (View on PubMed)

Other Identifiers

01KG2305

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2023-509970-43-01

Identifier Type: CTIS

Identifier Source: secondary_id

TATRA

Identifier Type: -

Identifier Source: org_study_id