Tranexamic Acid for Reduction of Transfusion in Abdominal Surgery

Phase 3

Recruiting

• Conditions: Surgical Blood Loss; Transfusion-dependent Anemia; Abdomen Disease
• Interventions: Drug: Tranexamic Acid; Drug: Placebo

• Registration Number: NCT06414031
• Lead Sponsor: Ulrich Ronellenfitsch, MD

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-10
• Study First Submitted QC: 2024-05-10
• Study First Posted: 2024-05-14
• Study Start: 2024-06-17
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-12
• Last Update Posted: 2024-10-15
• Primary Completion: 2025-11-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 850

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic acid	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)
Placebo	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.

Primary Outcome Measures

Name	Time	Method
Transfusion necessity	Until hospital discharge or 30 days postoperatively, whatever occurs earlier	Intra- or postoperative transfusion of at least one unit of packed red blood cells

Secondary Outcome Measures

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

Trial Locations

Locations (2)

University Hospital Carl Gustav Carus Dresden; 🇩🇪 Dresden, Saxony, Germany

University Hospital, Dpt. of Abdominal, Vascular and Endocrine Surgery; 🇩🇪 Halle (Saale), Germany