Intravenous vs. Topical Tranexamic Acid in Revision THA (VITALITY-X) (VITALITY-X)
|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 ]
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|