Abdomen Disease, Surgical Blood Loss, Transfusion-dependent Anemia
Conditions
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.
Interventions
DRUGTranexamic Acid
Intravenous administration
DRUGPlacebo
Intravenous administration
Sponsors
Ulrich Ronellenfitsch, MD
German Federal Ministry of Education and Research
Coordinating Centre for Clinical Trials Halle
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Transfusion amount | Until hospital discharge or 30 days postoperatively, whatever occurs earlier | Number of transfused units of packed red blood cells per patient |
| 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 |
| 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 |
Countries
Germany
Contacts
CONTACTUlrich Ronellenfitsch, MD
PRINCIPAL_INVESTIGATORUlrich Ronellenfitsch, MD
Medical Faculty of the Martin Luther University Halle-Wittenberg
Outcome results
None listed