Tranexamic Acid for Reduction of Transfusion in Abdominal Surgery

NCT06414031 | Recruiting Phase 3 DMC

• 3 other identifiers: TATRA01KG23052023-509970-43-01
• Study Type: interventional
• Target: 850
• Locations: 1 country
• Sites: 2

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; Abdomen Disease; Transfusion-dependent Anemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Transfusion amount

  Until hospital discharge or 30 days postoperatively, whatever occurs earlier

• Blood loss

  From skin incision to suture

• Postoperative complications and mortality

  Until hospital discharge or 30 days postoperatively, whatever occurs earlier

• Length of hospital stay

  From hospital admission to discharge

• Operation time

  From skin incision to suture

Study Arms (2)

Tranexamic acid

EXPERIMENTAL

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

Drug: Tranexamic Acid

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Tranexamic Acid DRUG

Intravenous administration

Also known as: Tranexamsäure Carinopharm 100mg/ml

Tranexamic acid

Placebo DRUG

Intravenous administration

Also known as: Isotone Kochsalz-Lösung 0,9% Infusionslösung

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or above
• 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 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).

You may not qualify if:

• 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.
• Thrombocytopenia with platelets \<60 x 109 /L
• Confirmed bleeding disorder with the need for specific preventive perioperative treatment (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 tranexamic acid
• Recent (\<30 days) thromboembolic event
• History of medically confirmed convulsions
• In female subjects: pregnancy or lactation

Sponsors & Collaborators

• German Federal Ministry of Education and Research: collaborator
• Coordinating Centre for Clinical Trials Halle: collaborator
• Ulrich Ronellenfitsch, MD: lead

Study Sites (2)

University Hospital Carl Gustav Carus Dresden

Dresden, Saxony, 01307, Germany

RECRUITING

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

Halle, 06120, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 39425234 DERIVED

MeSH Terms

Conditions

Blood Loss, Surgical

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Ulrich Ronellenfitsch, MD

  Medical Faculty of the Martin Luther University Halle-Wittenberg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ulrich Ronellenfitsch, MD

CONTACT

+493455572327; ulrich.ronellenfitsch@uk-halle.de

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Evidence-based Abdominal Surgical Oncology

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 14, 2024
• Study Start: June 17, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: IPD will be made available after analysis of the primary outcome and after publication of pertaining results.
• Access Criteria: Individual de-identified individual participant data will be shared with other researchers upon reasonable and justified request

Locations

DE (2)