Autoplex Versus Proplex: A Controlled, Double-Blind Study of Effectiveness in Acute Hemarthroses in Hemophiliacs With Inhibitors to Factor VIII

• Published in: Blood Vol. 62; no. 5; pp. 1135 - 1138
• Main Authors: Lusher, J.M., Blatt, P.M., Penner, J.A., Aledort, L.M., Levine, P.H., White, G.C., Warner, A.I., Whitehurst, D.A.
• Format: Journal Article
• Language: English
• Published: Washington, DC Elsevier Inc 01.11.1983; The Americain Society of Hematology
• Subjects: Biological and medical sciences; Blood Coagulation Factors - therapeutic use; Clinical Trials as Topic; Double-Blind Method; Factor IX - therapeutic use; Factor IXa; Factor VIII - antagonists & inhibitors; Hemarthrosis - drug therapy; Hematologic and hematopoietic diseases; Humans; Medical sciences; Platelet diseases and coagulopathies; Hemarthrosis; Hemophilia
• DOI: 10.1182/blood.V62.5.1135.1135
• ISSN: 0006-4971

In view of uncontrolled observations and anecdotal reports suggesting that the activated PCC, Autoplex, was much more effective than standard (non-activated) PCC in controlling bleeding in hemophiliacs with inhibitors, a controlled double-blind study was designed to compare the effectiveness of Autoplex and Proplex. Acute hemarthrosis was chosen for study as this common but non-life-threatening lesion lends itself well to controlled study. A single dose of “unknown” product (Autoplex 75 FECU/kg; Autoplex 50 FECU/kg; or Proplex 75 FIX U/kg) was given, and effectiveness was judged at 6 hr. By all criteria of efficacy, there were no significant differences between the products. It is noteworthy that a single dose of PCC was judged effective in 50% of episodes, a figure that is consistent with other published clinical trials. In this model, no additional benefit was derived from using the activated PCC, Autoplex, in either dosage.