Clinical trial NCT06414031: Tranexamic Acid for Reduction of Transfusion in Abdominal Surgery
Official title: Tranexamic Acid for Reduction of Intra- and Postoperative Transfusion Requirements in Elective Abdominal Surgery: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Surgical Blood Loss
Transfusion-dependent Anemia
Abdomen Disease
Lead sponsor: Martin-Luther-Universität Halle-Wittenberg
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
name: Coordinating Centre for Clinical Trials Halle
First posted: 2024-05-14
Enrollment: 850
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Transfusion necessity
timeFrame: Until hospital discharge or 30 days postoperatively, whatever occurs earlier
Secondary outcomes:
measure: Transfusion amount
timeFrame: Until hospital discharge or 30 days postoperatively, whatever occurs earlier
measure: Blood loss
timeFrame: From skin incision to suture
measure: Postoperative complications and mortality
timeFrame: Until hospital discharge or 30 days postoperatively, whatever occurs earlier
measure: Length of hospital stay
timeFrame: From hospital admission to discharge
measure: Operation time
timeFrame: From skin incision to suture
measure: Anesthesia time
timeFrame: From anesthesia induction to end of anesthesia
measure: D-dimer levels
timeFrame: Until hospital discharge or 30 days postoperatively, whatever occurs earlier
measure: Adverse events
timeFrame: Until hospital discharge or 30 days postoperatively, whatever occurs earlier
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: University Hospital Carl Gustav Carus Dresden
state: Saxony
city: Halle (Saale)
country: Germany
facility: University Hospital, Dpt. of Abdominal, Vascular and Endocrine Surgery
Study officials:
affiliation: Medical Faculty of the Martin Luther University Halle-Wittenberg
name: Ulrich Ronellenfitsch, MD
role: PRINCIPAL_INVESTIGATOR
References: