Tranexamic Acid
DrugTopical tranexamic acid (2g/100mL 0.9% saline)
Other names: cyclokapron
NCT Number: NCT01683955
This study aims to assess postoperative blood loss and transfusion rates in total hip replacement after one-time administration of topical tranexamic acid.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
HFH Main campus, Detroit, Michigan, United States
Autologous (donor) blood transfusion is an expensive and common occurrence after total hip replacement. There have been many proposed adjunctive measures to decrease intraoperative and postoperative blood loss during such surgery. Most of these include thrombin inhibition, so-called "minimally- invasive" techniques or instrumentation, or other adjunctive drugs. Hitherto, tranexamic acid, a specific drug that promotes part of the clotting cascade, has been used extensively in multiple areas of surgery with multiple studies evaluating its efficacy in cardiac surgery, spinal procedures, and as a dental swishing solution after tooth extraction. There have been small studies evaluating intravenous tranexamic acid and its effect on total hip replacements, with some promising results. The topical form of TA has been evaluated in only one prospective, randomized clinical trial with a significant decrease in postoperative blood loss and a trend towards decreased autologous blood transfusion rates. This study proposes to further evaluate tranexamic acid as an inexpensive and viable option for use in total hip arthroplasty. The topical form of the drug has been shown to achieve these hemostatic effects without increasing the risk of blood clots after surgery. A rigorous analysis of the effects of tranexamic acid demand a more standardized approach. Such a regimen is practiced at Henry Ford Hospital as all patients on the Adult Reconstruction service are placed on an identical dose of enoxaparin (a subcutaneous blood thinner) postoperatively for two weeks.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Topical tranexamic acid (2g/100mL 0.9% saline)
Other names: cyclokapron
100mL 0.9% sterile saline
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 days
Preoperative and lowest postoperative hemoglobin
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 days
number of units transfused postoperatively
Henry Ford Health System
Other
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