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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05710146
Other study ID # STU#00215778
Secondary ID
Status Withdrawn
Phase Phase 3
First received
Last updated
Start date December 2023
Est. completion date September 2024

Study information

Verified date January 2023
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Withdrawn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)

Study Design


Intervention

Drug:
Tranexamic acid
1 injection of 15mg/kg of TXA in 100mL of normal saline
Placebo
1 injection of 100mL of normal saline

Locations

Country Name City State
United States Northwestern University Feinberg School of Medicine Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

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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