Clinical trial

The Effect of Tranexamic Acid on Blood Coagulation in Total Hip Arthroplasty Surgery Based on Rotational Thromboelastometry (ROTEM®).

Name

18D.581

Description

Total hip arthroplasty (THA) is associated with blood loss ranging from 300 to 2000 mL. Tranexamic acid (TXA) is frequently administered prophylactically during this procedure to reduce blood loss by inhibiting fibrinolysis or by stopping naturally occurring clot resolution. TXA is employed currently based on a surgeon's preference. The objective of this study is to quantitate the degree of fibrinolysis using rotational thromboelastometry (ROTEM) and investigate the role of TXA prophylaxis on blood loss in patients undergoing THA in a double-blind fashion. Our hypothesis is that fibrinolysis is minimal at most and TXA prophylaxis is not necessary during THA. All patients, whether they receive TXA or normal saline, will not be at risk, as at this time no data exists to determine which approach is safer or more effective. This is the first study to compare TXA vs. placebo in a double-blinded, randomized controlled trial.

Trial arms

Trial start

2019-05-20

Estimated PCD

2022-12-20

Trial end

2022-12-20

Status

Completed

Treatment

Tranexamic Acid

tranexamic acid will be administered intravenously after induction of anesthesia (a bolus of 10 mg/kg or maximal dose of 1g).

Arms:

tranexamic acid

Placebo

Patients in the placebo group will receive normal saline (a bolus of sodium chloride 0.9%, 0.1 mL/kg or maximal dose of 10 mL).

Arms:

Normal saline

Size

Primary endpoint

Fibrinolysis

after induction of anesthesia (baseline),

Fibrinolysis

45 min after drug administration,

Fibrinolysis

one hour after the end of surgery

Eligibility criteria

Inclusion Criteria: * The study population will include total of 200 adults (age range of 18 - 85 years) who are in the American Society of Anesthesiologists (ASA) Physical Status (PS) 1-3. Inclusion criteria are patients undergoing unilateral, primary, total hip arthroplasty. Exclusion Criteria: * Exclusion criteria include patient's refusal, patients with history of significant coagulopathy or on anticoagulation therapy. Female patients who are pregnant or nursing will be excluded. In addition, patients with anemia (Hb \< 8 g/dL) or who received blood transfusion within one week before surgery will be excluded. Patient receiving subcutaneous heparin on the same day prior to surgery will be also excluded.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'double-blinded randomized controlled trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 50, 'type': 'ACTUAL'}}

Updated at

2023-04-14

1 organization

1 product

1 drug

5 indications

Organization

Thomas Jefferson University

Product

Tranexamic Acid

Indication

Coagulation; Intravascular