A Study to Evaluate the Effect of GRF6021 on Postoperative Recovery Following Primary Hip or Knee Arthroplasty
Trial ID or NCT#
Status
Purpose
This study will evaluate the safety, tolerability and effect of GRF6021 on clinical recovery parameters in participants undergoing primary hip or knee arthroplasty.
Official Title
A Randomized, Placebo-Controlled, Double-Blind Pilot Study to Evaluate the Effect of GRF6021 on Intracellular Signaling Cascades in Blood Leukocytes and Postoperative Recovery Following Primary Hip or Knee Arthroplasty
Eligibility Criteria
- * Men and women 50-85 years of age scheduled to undergo primary total hip or knee replacement surgery.* Estimated glomerular filtration rate ≥ 45 mL/min/1.73 m2 .
- * Blood coagulation disorders.* Participants who started chronic anticoagulant therapy (warfarin, heparin, low-molecular weight heparin, or Factor Xa inhibitors) in the last 6 months* Hypercoagulable state.* Prior hypersensitivity to any human blood product including plasma.* Treatment with any human blood product, including transfusions and IV immunoglobulin, during the 6 months prior to screening.* History of immunoglobulin A or haptoglobin deficiency.* Major surgery, trauma or injury in the last 3 months or minor surgery in the last 1 month.* Heart disease or congestive heart failure in the 6 months prior to dosing.* Poorly controlled hypertension.* Severe anemia.* Functional impairment of major joint or lower extremity other than joint undergoing surgery.
Investigator(s)
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Contact
Martha Tingle
View on ClinicalTrials.gov