Status:
TERMINATED
Role of Topical Tranexamic Acid in Total Hip Arthroplasty
Lead Sponsor:
Northwell Health
Conditions:
Post Operative Blood Loss
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Total hip arthroplasty (THA) is a procedure associated with perioperative blood loss, requiring blood transfusions in some patients. The major cause of this blood loss is due to surgical trauma that i...
Eligibility Criteria
Inclusion
- 18-80 years of age.
- Male or female.
- Degenerative joint disease of hip joint.
- Primary uncemented total hip arthroplasty.
- Willingness to participate in the study, follow up at regular intervals
Exclusion
- Known allergy to tranexamic acid
- History of any acquired disturbances of color vision
- Preoperative anemia on basis of pre-operative lab work up (a hemoglobin value of \<11 g/dL in females and \<12 g/dL in males)
- History of previous myocardial infarction
- History of arterial or venous thromboembolic disease
- History of fibrinolytic disorders requiring intraoperative antifibrinolytic treatment, coagulopathy in the past and/or as identified by a preoperative platelet count of \<150,000/mm3, an international normalized ratio of \>1.5, or a prolonged partial thromboplastin time
- Pregnancy (h/o any missed menstrual periods in a women of reproductive age group)
- Breastfeeding
- Refusal of blood products
- Preoperative use of anticoagulant therapy within five days before surgery
- Medical issues that may pose complications for surgery and would disqualify patient for surgery regardless of clinical trial (e.g. renal and hepatic failure)
- Major comorbidities (e.g. severe ischemic heart disease )
- Severe pulmonary disease
- Preoperative blood donation
- Participation in another clinical trial involving pharmaceutical drugs
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT01866943
Start Date
November 1 2011
End Date
October 1 2016
Last Update
March 13 2018
Active Locations (1)
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1
North Shore Long Island Jewish Lenox Hill Hospital
New York, New York, United States, 10075