A Prospective, Randomized Controlled Trial to Evaluate the Efficacy of Cell Saver to Redue Blood Loss in One-stage Bilateral Total Hip Arthroplasty (THA)

Rothman Institute Orthopaedics2 个研究点分布在 1 个国家开始时间: 2011年11月最近更新: 2011年11月9日

适应症

试验速览

This study will investigate the efficacy of using cell saver during bilater total hip arthroplasty

•Subject is over 21 years of age
•Subject with bilateral degenerative disease of hips who are candidate for one-stage bilateral THA
•Subject willing and able to provide written informed consent

•Subject with significant comorbidities identified by Charleston index of ≥ 3
•Subject with malignancy
•Subject with history of heart disease, myocardial infarction, pulmonary insufficiency, pulmonary embolus, documented fat emboli syndrome, adult respiratory distress syndrome, documented patent ductus arteriosus or septal defect, chronic renal failure and/or acute hepatic failure or chirhosis
•Subjects with hematologic disorders such as anemia (Hb < 10 g/dL) and sickle cell disease, acquired or congenital coagulopathies, acquired or congenital bleeding disorders,
•Subject who received anticoagulant such as aspirin or Warfarin (Coumadin) or antiplatelet agents such as clopidogrel (Plavix) within 7 days of surgery
•Subject who received hemostatic agents such as tranexamic acid and aprotinin
•Subjects utilizing acute normovolumic haemodilution
•Subject is not permitted to remain without his/her anti-coagulant regimen (eg Plavix) for 48 hours postoperatively
•Subject is known to be pregnant.
•Subject has erythropoietin agonist/stimulating agent within 90 days prior to surgery.
•Presence of contaminants such as urine, fat, bowel contents, and most importantly infection in the operative field
•Presence of vasoactive drugs such as papaverine in the operative field

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