Tranexamic Acid for Reduction of Transfusion in Abdominal Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tranexamic Acid, Placebo.
- Who it may be relevant to
- Registry conditions: Surgical Blood Loss, Transfusion-dependent Anemia, Abdomen Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Tranexamic Acid for Reduction of Intra- and Postoperative Transfusion Requirements in Elective Abdominal Surgery: Randomized Controlled Trial
Overview
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.
Interventions
- Drug Tranexamic Acid
Intravenous administration - Drug Placebo
Intravenous administration
Primary outcome measures
- Transfusion necessity [Time frame: Until hospital discharge or 30 days postoperatively, whatever occurs earlier]
Secondary outcome measures (8)
- Transfusion amount [Time frame: Until hospital discharge or 30 days postoperatively, whatever occurs earlier]
- Blood loss [Time frame: From skin incision to suture]
- Postoperative complications and mortality [Time frame: Until hospital discharge or 30 days postoperatively, whatever occurs earlier]
- Length of hospital stay [Time frame: From hospital admission to discharge]
- Operation time [Time frame: From skin incision to suture]
- Anesthesia time [Time frame: From anesthesia induction to end of anesthesia]
- D-dimer levels [Time frame: Until hospital discharge or 30 days postoperatively, whatever occurs earlier]
- Adverse events [Time frame: Until hospital discharge or 30 days postoperatively, whatever occurs earlier]
Eligibility criteria
Inclusion criteria
- 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).
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Germany · 2 centers
- University Hospital Carl Gustav Carus Dresden — Dresden
- University Hospital, Dpt. of Abdominal, Vascular and Endocrine Surgery — Halle
Publications
- 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 PMID 39425234
Identifiers
NCT: NCT06414031 · TATRA · 01KG2305 · 2023-509970-43-01