Blood Loss Clinical Trial
Official title:
Assessing the Efficacy of Tranexamic Acid (TXA) in Hip Arthroscopy: A Randomized, Controlled Trial
Verified date | January 2023 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 2024 |
Est. primary completion date | March 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Northwestern University Feinberg School of Medicine | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Northwestern University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual clarity grade | Surgeon-Reported Visual Clarity Grade Grade 1: Active bleeding leading to poor visibility Grade 2: Moderate amount of blood mixed with the irrigation fluid, where the visibility is slightly affected but is acceptable for operating Grade 3: Little or no bleeding; the visibility is excellent to perform the operation | Throughout surgical procedure | |
Secondary | Intra-operative Visibility Score | Number of intra-operative flushes required.
Scores as follows: Greater than 13 saline flushes 8-12 saline flushes 4-7 saline flushes 1-3 saline flushes 5 = Zero saline flushes |
Throughout surgical procedure | |
Secondary | Operative traction time | Minutes of the procedure in traction | Throughout surgical procedure | |
Secondary | Estimated blood loss | Estimated blood loss during procedure in mL | Throughout surgical procedure | |
Secondary | Post-operative dressing changes | Count number of times post-op dressing was changed | From time of surgery completion through 2 weeks post-op | |
Secondary | Visual Analog Scale (VAS) Pain Score | Scored from 0 (no pain) to 10 (worst possible pain) | Pre-operative baseline up through 24 weeks after surgery | |
Secondary | Complications | Number of complications and type of complication will be recorded | From surgery start time through first 6 months post-op | |
Secondary | Thromboembolic events | Number of thromboembolic events | From surgery start time through first 6 months post-op | |
Secondary | modified Harris Hip Score (mHHS) | Subscales regarding pain severity (1 item, 0-44 points), and function (7 items, 0-47 points). Higher overall score corresponds to less disability. | Pre-operative baseline up through 24 weeks after surgery | |
Secondary | International Hip Outcome Tool 12 (iHOT) | 12 questions scored from 0 to 100, with 100 being the best function and least amount of symptoms. The final iHOT score equates to the mean of the 12 scores. | Pre-operative baseline up through 24 weeks after surgery |
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