A Phase 4 interventional study of Tranexamic acid and Floseal® in Knee Osteoarthritis, sponsored by University of Sao Paulo General Hospital. Status unknown at 1 site in Brazil. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-06-02.
Sponsored by University of Sao Paulo General Hospital · Phase 4, Interventional, and Treatment
The total knee arthroplasty (TKA) is a well established option for the treatment of osteoarthritis in this joint. Nevertheless, there are still some concerns related to the peri-operative management of elderly patients, highlighting the complications related to medical comorbidity and bleeding produced by surgery. One of the proposed methods to decrease postoperative bleeding, which has been accumulating favorable evidence, is the use of tranexamic acid (TA). Several studies (including prospective randomized trials with placebo group) showed excellent results with TA intravenous administration during TKA, reducing the amount of bleeding, the drop in hemoglobin and the need for blood transfusion. Another alternative to minimize bleeding is the use of topical hemostatic agent Floseal®, composed of thrombin and bovine gelatin. This substance has presented significant benefits on bleeding control in several areas of medicine, including orthopedic surgery, but no action has yet been established in TKA. The main objective is to evaluate the amount of bleeding, the drop in hemoglobin and the need for blood transfusion after TKA, comparing the use of TA, Floseal® and a control group. The secondary objective is to evaluate the rate of adverse events in the studied groups.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's planned enrollment of 45 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →University of Sao Paulo General Hospital is the lead sponsor of 595 studies on the registry; 98 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
A dose of tranexamic acid (10mg/Kg) will be administered 20 minutes before inflating the pneumatic tourniquet and another dose 15 minutes after the tourniquet release.
Drug: Tranexamic acid
Floseal® will be applied in regions of potential bleeding before the release of the pneumatic tourniquet.
Drug: Floseal®
Also known as: TA
Amount of bleeding
Measure of the drain volume on the first two days post-operative
Time frame: First two days post-operative
Drop in hemoglobin
Difference between the preoperative hemoglobin and hemoglobin in the third postoperative
Time frame: Three days postoperative
Adverse events
Time frame: 1 month
This study is status unknown, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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University of Sao Paulo General Hospital