Clinical trial

Assessing the Efficacy of Tranexamic Acid (TXA) in Hip Arthroscopy: A Randomized, Controlled Trial

Name
STU#00215778
Description
The primary goal of this study will be to determine if perioperative IV Tranexamic Acid (TXA) administration will reduce intra-operative bleeding and subsequently improve visual clarity during surgery and reduce operative traction time in patients undergoing hip arthroscopy. Additionally, this study aims to determine whether IV TXA injections will reduce post-operative pain and affect hip-specific patient-reported outcomes in patients undergoing hip arthroscopy.
Trial arms
Trial start
2023-12-01
Estimated PCD
2024-03-01
Trial end
2024-09-01
Status
Withdrawn
Phase
Early phase I
Treatment
Tranexamic acid
1 injection of 15mg/kg of TXA in 100mL of normal saline
Arms:
Tranexamic Acid
Other names:
TXA, Cyklokapron
Placebo
1 injection of 100mL of normal saline
Arms:
Placebo
Other names:
normal saline
Primary endpoint
Visual clarity grade
Throughout surgical procedure
Eligibility criteria
Inclusion Criteria: * Age 18 years or older * Scheduled to undergo primary hip arthroscopy for any intra-articular procedure * Able to complete and understand study materials in English Exclusion Criteria: * Age under 18 years * Cannot complete and understand study materials in English * Patients undergoing revision surgery * Patients who have had previous surgery to the study joint * Patients on drugs that interfere with coagulation or TXA clearance * Patients with a known allergy to TXA * Patients with any of the following comorbidities * Bleeding and/or coagulative disorders * Renal impairment * Sickle cell disease * Thrombotic diseases * Comorbidities preventing surgery (including pregnancy)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}
Updated at
2023-02-02

1 organization

1 product

1 drug

5 indications

Indication
Hip Injuries
Indication
Hemorrhage