Topical Tranexamic Acid (TXA) in Joint Arthroplasty
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|ClinicalTrials.gov Identifier: NCT01937559|
Recruitment Status : Recruiting
First Posted : September 9, 2013
Last Update Posted : February 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis Hip Arthropathy Shoulder Arthropathy||Biological: Tranexaminic Acid (TXA) Drug: Normal saline||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Topical Application of Tranexamic Acid in Joint Arthroplasty|
|Study Start Date :||April 2013|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||June 2019|
Experimental: Antifibrinolytic agent
Tranexaminic acid (TXA)
Biological: Tranexaminic Acid (TXA)
1.5g of TXA in 100ml normal saline solution
Other Name: Cyklokapron
Placebo Comparator: Saline
Drug: Normal saline
- Post-operative blood loss [ Time Frame: Duration of hospital stay ]Blood loss will be calculated as the difference between the preoperative hemoglobin and the lowest postoperative hemoglobin during the hospital stay or the lowest postoperative hemoglobin prior to blood transfusion.
- Perioperative blood transfusions [ Time Frame: Duration of surgery ]
- Number of blood units transfused [ Time Frame: Duration of surgery ]
- Rate of surgical infections [ Time Frame: Duration of hospital stay ]
- Length of hospital stay [ Time Frame: Duration of hospital stay ]
- Time until start of rehabilitation program [ Time Frame: Up to 3 weeks post-surgery ]
- Postoperative changes in joint function [ Time Frame: Duration of hospital stay ]Increase or reduction in ROM of the knee will be accounted for during the patient's stay at the hospital post-surgery.
- Shoulder outcome scores [ Time Frame: 6 months post-surgery ]Shoulder outcome scores will include a PENN derived ASES form.
- General outcome scores [ Time Frame: 6 months post-surgery ]General outcome measures will include EQ-5D, GROC and SANE forms.
- Hip outcome scores [ Time Frame: 6 months ]Hip outcome measurements will include Harris Hip score and the WOMAC forms.
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): NCT01937559
|Contact: Kyle Adams, BSfirstname.lastname@example.org|
|United States, South Carolina|
|Steadman Hawkins Clinic of the Carolinas - Greenville Health System||Recruiting|
|Greenville, South Carolina, United States, 29615|
|Contact: Carlisle Shealy, MD 864-454-7458 email@example.com|
|Principal Investigator: Brian Burnikel, MD|
|Sub-Investigator: Richard J Hawkins, MD|
|Sub-Investigator: Michael J Kissenberth, MD|
|Sub-Investigator: Stefan Tolan, MD|
|Sub-Investigator: Brayton R Shirley, MD|
|Sub-Investigator: Phillip H Wessinger, MD|
|Principal Investigator:||Brian Burnikel, MD||Steadman Hawkins Clinic of the Carolinas - Greenville Health System|