The Effect of Tranexamic Acid (TXA) on Visualization During Shoulder Arthroscopy
Primary Purpose
Shoulder Arthroscopy, Operative Bleeding, Postoperative Pain
Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tranexamic acid
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Arthroscopy
Eligibility Criteria
Inclusion Criteria:
- participants aged 18-80
- participants with an ASA (American Society of Anesthesiologists) score 1-3
- participants with a surgical indication of full thickness small to massive rotator cuff tear.
Exclusion Criteria:
- pregnant females,
- participants with a known allergy to tranexamic acid,
- participants with active thromboembolic disease,
- participants with seizure disorder,
- participants with prior cerebrovascular accident (CVA),
- history of cardiac stents or past history of thromboembolic disease,
- presence of full-thickness subscapularis tear (>50%),
- participants with irreparable rotator cuff tears.
Sites / Locations
- Rothman Orthopaedic Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Group 1: TXA group
Group 2: Control Group
Arm Description
Patient will receive 1 gram intravenous TXA prior to surgery
Patient will not receive TXA prior to surgery
Outcomes
Primary Outcome Measures
Changes in operative factors
change in pump pressure (ΔP) during shoulder arthroscopy with a change in pump pressure of 15 mmHg set as the marker of surgeon visualization of the shoulder joint during surgery.
Postoperative pain
Investigators will be measuring whether there is a decrease in participants pain after surgery as assessed by visual analog score 7 days after surgery
Secondary Outcome Measures
Full Information
NCT ID
NCT04610164
First Posted
October 21, 2020
Last Updated
October 29, 2020
Sponsor
Rothman Institute Orthopaedics
1. Study Identification
Unique Protocol Identification Number
NCT04610164
Brief Title
The Effect of Tranexamic Acid (TXA) on Visualization During Shoulder Arthroscopy
Official Title
The Effect of Tranexamic Acid on Visualization During Shoulder Arthroscopy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 19, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rothman Institute Orthopaedics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
Tranexamic acid has seen an increase in use over the past decade in hip and knee arthroplasty as well as spine surgery with more recent use seen in total shoulder arthroplasty (TSA). The mechanism of action of TXA is as a lysine analogue that competitively inhibits the conversion of plasminogen to plasmin thus resulting in its antifibrinolytic activity. Investigators have showed that compared with placebo TXA had a statistically significant effect on blood and postoperative hemoglobin levels in TSA. To date there are no studies investigating the effect of TXA in arthroscopy of any kind or studies examining the ability of TXA to aid in surgeon visualization in arthroscopic procedures. The investigators of this study will use change in pump pressure as a surrogate objective measure for surgeon visualization. The hypothesis is that participants who receive TXA will have a lower change in pump pressure compared to participants who do not receive TXA.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Arthroscopy, Operative Bleeding, Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1: TXA group
Arm Type
Experimental
Arm Description
Patient will receive 1 gram intravenous TXA prior to surgery
Arm Title
Group 2: Control Group
Arm Type
No Intervention
Arm Description
Patient will not receive TXA prior to surgery
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid
Intervention Description
Prior to surgery, the patient will receive 1 gram of IV TXA
Primary Outcome Measure Information:
Title
Changes in operative factors
Description
change in pump pressure (ΔP) during shoulder arthroscopy with a change in pump pressure of 15 mmHg set as the marker of surgeon visualization of the shoulder joint during surgery.
Time Frame
2 hours
Title
Postoperative pain
Description
Investigators will be measuring whether there is a decrease in participants pain after surgery as assessed by visual analog score 7 days after surgery
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
participants aged 18-80
participants with an ASA (American Society of Anesthesiologists) score 1-3
participants with a surgical indication of full thickness small to massive rotator cuff tear.
Exclusion Criteria:
pregnant females,
participants with a known allergy to tranexamic acid,
participants with active thromboembolic disease,
participants with seizure disorder,
participants with prior cerebrovascular accident (CVA),
history of cardiac stents or past history of thromboembolic disease,
presence of full-thickness subscapularis tear (>50%),
participants with irreparable rotator cuff tears.
Facility Information:
Facility Name
Rothman Orthopaedic Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Effect of Tranexamic Acid (TXA) on Visualization During Shoulder Arthroscopy
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