Clinical trial
Evaluation of the Use of Tranexamic Acid in Tibial Osteotomies: a Randomised Controlled Clinical Trial.
Name
TXA-HTO
Description
A randomised controlled double-blind clinical trial focused on the evaluation of the effectiveness of the tranexamic acid on bleeding, pain and wound complications reduction in tibial osteotomies.
All the 84 included patients will be randomized in one of the two arms, will undergo to a tibial osteotomy and then will prospectively evaluate at different follow ups until 60 days post-surgery
Trial arms
Trial start
2021-02-22
Estimated PCD
2025-02-22
Trial end
2025-02-22
Status
Recruiting
Treatment
Tibial osteotomy with Tranexamic acid
Patients who will be in the treatment arm after randomisation will receive 100ml saline with a dosage of 20 mg/kg tranexamic acid intravenously at induction. An additional administration of tranexamic acid (10 mg/kg in 100ml intravenous saline) will be given as a booster at the end of the surgical procedure.
All the patients will undergo to the same tibial osteotomy procedure.
Arms:
Tranexamic arm
Tibial osteotomy without Tranexamic acid
Patients in this arm will undergo to the tibial osteotomy procedure as by clinical practice
Arms:
control arm
Size
84
Primary endpoint
Perioperative blood loss (haemoglobin balance):
Basal vs the first post operative day
Eligibility criteria
Inclusion Criteria:
1. Male or female patients aged between 18 and 70 years;
2. Single-part tibiofemoral osteoarthritis (K-L 1-3), axial deviation \> 5°;
3. Surgical indication for corrective osteotomy;
4. Isolated osteotomy surgical procedure.
Exclusion Criteria:
1. Contraindication criteria for the administration of tranexamic acid, as assessed by the Anaesthesia and Resuscitation specialist during the pre-operative visit. The following will be considered absolute contraindications: epilepsy, thrombophilia and known allergy to the active substance, severe renal insufficiency and acute venous or arterial thrombosis, while the following will be considered relative contraindications: coronary stents in patients who have discontinued treatment with antiplatelet agents and previous deep vein thrombosis;
2. Known pro-thrombotic conditions (coagulation factor mutations, pregnancy status, previous pulmonary thromboembolism);
3. BMI \> 40;
4. Incapacitated patients;
5. Patients abusing alcoholic beverages, drugs or medication.
6. Patients who are pregnant or breastfeeding.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 84, 'type': 'ESTIMATED'}}
Updated at
2024-04-22
1 organization
1 product
2 indications
Organization
Istituto Ortopedico RizzoliProduct
Tranexamic acidIndication
Osteoarthritis