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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Surgical Blood Loss; Transfusion-dependent Anemia; Abdomen Disease
• Intervention / Treatment: Drug: Placebo; Drug: Tranexamic Acid

• Study Type: Interventional
• Enrollment (Estimated): 850
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Ulrich Ronellenfitsch, MD; Phone Number: +493455572327; Email: ulrich.ronellenfitsch@uk-halle.de

Study Locations

• Germany
  • Halle (Saale), Germany, 06120
    • University Hospital, Dpt. of Abdominal, Vascular and Endocrine Surgery
    • Contact: Ulrich Ronellenfitsch, MD; Phone Number: +49-345-5572327; Email: ulrich.ronellenfitsch@uk-halle.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Drug: Tranexamic Acid; Intravenous administration; Other Names: Tranexamsäure Carinopharm 100mg/ml
Placebo Comparator: 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.	Drug: Placebo; Intravenous administration; Other Names: Isotone Kochsalz-Lösung 0,9% Infusionslösung

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transfusion amount	Number of transfused units of packed red blood cells per patient	Until hospital discharge or 30 days postoperatively, whatever occurs earlier
Blood loss	Estimated intraoperative blood loss	From skin incision to suture
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
Length of hospital stay	Time period from hospital admission to discharge	From hospital admission to discharge
Operation time	Time period from skin incision to suture	From skin incision to suture
Anesthesia time	Time period from anesthesia induction to end of anesthesia	From anesthesia induction to end of anesthesia
D-dimer levels	Serum levels of D-dimers	Until hospital discharge or 30 days postoperatively, whatever occurs earlier
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

Collaborators and Investigators

• Sponsor: Ulrich Ronellenfitsch, MD
• Collaborators: German Federal Ministry of Education and Research; Coordinating Centre for Clinical Trials Halle
• Investigators: Principal Investigator: Ulrich Ronellenfitsch, MD, Medical Faculty of the Martin Luther University Halle-Wittenberg

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): November 30, 2025

Study Registration Dates

• First Submitted: May 10, 2024
• First Submitted That Met QC Criteria: May 10, 2024
• First Posted (Actual): May 14, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 14, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Intraoperative Complications; Blood Loss, Surgical; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: TATRA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No