Intravenous vs. Topical Tranexamic Acid in Revision THA (VITALITY-X) (VITALITY-X)
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|ClinicalTrials.gov Identifier: NCT02938962|
Recruitment Status : Unknown
Verified October 2016 by Mount Sinai Hospital, Canada.
Recruitment status was: Recruiting
First Posted : October 19, 2016
Last Update Posted : October 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Tranexamic Acid Blood Loss, Surgical Arthroplasty, Replacement, Hip||Drug: Tranexamic Acid||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Revision Total Hip Arthroplasty: Comparison of the Effects of Intravenous and Topically Administered Tranexamic Acid in a Prospective Randomized Trial (VITALITY-X)|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||November 2018|
Active Comparator: Intravenous TXA
The IV administration group will receive a single 20mg/kg dose of TXA prior to the skin incision.
Drug: Tranexamic Acid
Active Comparator: Topical TXA
The topical administration group will have a 100mL solution (3g TXA in 100cc of normal saline) instilled into the surgical field throughout the operative procedure; 50mL of the solution will be instilled after bony preparation of the acetabulum and/or femur and 50mL of the solution will be instilled prior to closure. The topical TXA solution will be allowed to bathe the wound for 5 minutes at each administration.
Drug: Tranexamic Acid
- Delta Hemoglobin [ Time Frame: Post-operative day #0 to post-operative day #5 ]Delta hemoglobin (defined as the change in hemoglobin from preoperative measurement to post-operative day 0, 1, 2, 3, 5).
- Allogenic blood units transfused [ Time Frame: through hospital admission, an average of 4 days ]
- Length of stay [ Time Frame: through hospital admission, an average of 4 days ]
- Estimated intra-operative blood loss as assessed by the anaesthesiology team [ Time Frame: Intra-operative ]
- Post-operative complications [ Time Frame: 3 months postoperatively ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02938962
|Contact: Paul Kuzyk, MDfirstname.lastname@example.org|
|Mount Sinai Hospital||Recruiting|
|Toronto, Ontario, Canada, M5G1X5|
|Contact: Paul Kuzyk, MD, MSc (416) 586-4653 email@example.com|
|Principal Investigator:||Paul Kuzyk, MD||MOUNT SINAI HOSPITAL|