Back to resultsTXA in Revision Total Shoulder Arthroplasty
Primary Purpose
Arthropathy Shoulder
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tranexamic acid
Sponsored by
About this trial
This is an interventional treatment trial for Arthropathy Shoulder
Eligibility Criteria
Inclusion Criteria:
- Patients older than 18 years old
- Patients younger than 90 years old
- Patients undergoing scheduled revision total shoulder arthroplasty
- Patients who consent to be randomized
Exclusion Criteria:
- Patients younger than 18
- Patients older than 90 years old
- Patients who are pregnant or breast-feeding women
- Patients who are allergic to tranexamic acid
- Patients with proximal humerus fracture or fracture sequelae
- Patients who use estrogen containing medications (i.e. oral contraceptive pills)
- Patients who have acquired disturbances of color vision
Patients with a history of any of the following diagnosis: '
- Subarachnoid hemorrhage
- Active intravascular clotting
- Severe pulmonary disease (FEV <50% normal)
- Plasma creatinine > 115 μmol/L in males, > 100 μmol/L in females, or hepatic failure)
- (Renal impairment serum creatinine > 1.5 times the upper limit of normal NYU)
- Preoperative anemia [Hemoglobin (Hb) < 11g/dL in females, Hb < 12 g/dL in males]
- Patients who refuse blood products
- Patients undergoing hormone replacement therapy
- Patients with diagnosed or self-reported cognitive dysfunction;
- Patients who are unable to understand or follow instructions;
- Patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart disease;
- Patients with BMI over 50
- Any patient that the investigators feel cannot comply with all study related procedures.
Sites / Locations
- NYU Langone Orthopedic Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Tranexamic acid (TXA)
Control
Arm Description
IV TXA
No TXA
Outcomes
Primary Outcome Measures
Total calculated total blood loss
The volume of perioperative blood loss will be determined on the basis of the blood volume and change in hemoglobin from preoperatively to 1 day postoperatively. The volume of total perioperative blood loss will be determined according to the following formula:
Total blood loss (ml) = 1000 x 〖Hb〗_loss/〖Hb〗_i
Total surgical drain output
The floor nurse will also document the amount of blood in the indwelling hemovac surgical drain placed in the operative shoulder joint. The drain output will be documented every 8 hours. We will record the drain output for the first 16 hours after surgery - essentially 2 output shifts. If patients are in the hospital longer, we will record the third 24 hour drain output.
Secondary Outcome Measures
Number of participants with presence of hematoma
Number of participants who needed a post-op blood transfusion
Operative time
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04650698
Brief Title
TXA in Revision Total Shoulder Arthroplasty
Official Title
The Effect of Tranexamic Acid on Calculated Total Blood Loss in Patients Undergoing Revision Shoulder Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
Enrollment rate was slower than anticipated.
Study Start Date
January 7, 2021 (Actual)
Primary Completion Date
March 12, 2023 (Actual)
Study Completion Date
March 12, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
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.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a phase IV, randomized, single-blind, single-center study comparing calculated total blood loss, surgical drain output and hematoma formation in patients who receive 2 doses of Tranexamic Acid (TXA) versus control group undergoing revision total shoulder arthroplasty. Patients will be randomized to either receive 2 doses of IV TXA, first dose prior to surgical incision and second dose given 3 hours later or to the control group, where no TXA will be administered.
Detailed Description
The objectives of the study are to compare the effectiveness of IV TXA on reducing calculated total blood loss, surgical drain output and hematoma formation in patients undergoing revision total shoulder arthroplasty.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthropathy Shoulder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
Neither the anesthesiologist or surgeon will be blinded to the patient's group assignment, as they will be the one performing the treatment. All other stakeholders (patient, other caregivers, and research staff collecting the data) will be blinded to the patient's group assignment.
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tranexamic acid (TXA)
Arm Type
Experimental
Arm Description
IV TXA
Arm Title
Control
Arm Type
No Intervention
Arm Description
No TXA
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid
Other Intervention Name(s)
TXA
Intervention Description
IV, Total Dosage: 2 grams (1 gram before surgical incision + 1 gram, 3 hours after first dose)
Primary Outcome Measure Information:
Title
Total calculated total blood loss
Description
The volume of perioperative blood loss will be determined on the basis of the blood volume and change in hemoglobin from preoperatively to 1 day postoperatively. The volume of total perioperative blood loss will be determined according to the following formula:
Total blood loss (ml) = 1000 x 〖Hb〗_loss/〖Hb〗_i
Time Frame
up to 24 hours post-op
Title
Total surgical drain output
Description
The floor nurse will also document the amount of blood in the indwelling hemovac surgical drain placed in the operative shoulder joint. The drain output will be documented every 8 hours. We will record the drain output for the first 16 hours after surgery - essentially 2 output shifts. If patients are in the hospital longer, we will record the third 24 hour drain output.
Time Frame
up to 24 hours post-op
Secondary Outcome Measure Information:
Title
Number of participants with presence of hematoma
Time Frame
2 weeks post-op
Title
Number of participants who needed a post-op blood transfusion
Time Frame
2 weeks post-op
Title
Operative time
Time Frame
During operation, up to 4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients older than 18 years old
Patients younger than 90 years old
Patients undergoing scheduled revision total shoulder arthroplasty
Patients who consent to be randomized
Exclusion Criteria:
Patients younger than 18
Patients older than 90 years old
Patients who are pregnant or breast-feeding women
Patients who are allergic to tranexamic acid
Patients with proximal humerus fracture or fracture sequelae
Patients who use estrogen containing medications (i.e. oral contraceptive pills)
Patients who have acquired disturbances of color vision
Patients with a history of any of the following diagnosis: '
Subarachnoid hemorrhage
Active intravascular clotting
Severe pulmonary disease (FEV <50% normal)
Plasma creatinine > 115 μmol/L in males, > 100 μmol/L in females, or hepatic failure)
(Renal impairment serum creatinine > 1.5 times the upper limit of normal NYU)
Preoperative anemia [Hemoglobin (Hb) < 11g/dL in females, Hb < 12 g/dL in males]
Patients who refuse blood products
Patients undergoing hormone replacement therapy
Patients with diagnosed or self-reported cognitive dysfunction;
Patients who are unable to understand or follow instructions;
Patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart disease;
Patients with BMI over 50
Any patient that the investigators feel cannot comply with all study related procedures.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arthur Hertling, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Orthopedic Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
The investigator who proposed to use the data upon reasonable request. Requests should be directed to Uchenna.Umeh@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
Learn more about this trial
TXA in Revision Total Shoulder Arthroplasty
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