A Study to Evaluate the Effect of GRF6021 on Postoperative Recovery Following Primary Hip or Knee Arthroplasty

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

This study will evaluate the safety, tolerability and effect of GRF6021 on clinical recovery parameters in participants undergoing primary hip or knee arthroplasty.

This is a randomized, placebo-controlled, double-blind pilot study to investigate the effects of GRF6021, a 5% human plasma protein fraction administered by intravenous (IV) infusion, on intracellular signaling cascades in blood leukocytes in participants undergoing primary hip or knee arthroplasty.

Inclusion 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 .

Exclusion Criteria:

• 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.