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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06414031
Other study ID # TATRA
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


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
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