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Controlled clinical trials with prothrombin complex concentrates.

J M Lusher

    Progress in Clinical and Biological Research
    |January 1, 1984
    PubMed
    Summary
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    Prothrombin complex concentrate (PCC) shows efficacy in about 50% of bleeding episodes for hemophilia patients with inhibitors. Future trials will explore activated PCC and refine study designs for better assessment of treatment effectiveness.

    Area of Science:

    • Hematology
    • Clinical Trials
    • Pharmacology

    Background:

    • Prothrombin complex concentrate (PCC) has been used since 1972 for hemophilia patients with inhibitors.
    • Previous reports on PCC efficacy are often anecdotal and conflicting.
    • Controlled studies are needed to evaluate PCC effectiveness.

    Purpose of the Study:

    • To review existing controlled studies on PCC for hemophiliacs with inhibitors.
    • To identify limitations in current trial designs for evaluating PCC efficacy.
    • To suggest improvements for future clinical trials.

    Main Methods:

    • Analysis of three completed double-blind, controlled studies evaluating PCC.
    • Focus on studies where acute hemarthrosis was the primary or predominant bleeding type.

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  • Review of limitations in assessing treatment response in clinical trials.

    • Main Results:

    • Non-activated PCC demonstrated effectiveness in approximately 50% of bleeding episodes across all three trials.
    • Despite limitations, a consistent efficacy rate was observed.
    • Acute hemarthrosis was the main focus of evaluated bleeding episodes.

    Conclusions:

    • Non-activated PCC has a notable, albeit limited, efficacy in managing bleeding episodes in hemophiliacs with inhibitors.
    • Future trials should consider activated PCC and refine methodologies.
    • Proposed modifications include excluding "target" joints and extending assessment periods.