Autoplex Versus Proplex: A Controlled, Double-Blind Study of Effectiveness in Acute Hemarthroses in Hemophiliacs With Inhibitors to Factor VIII
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 Auto...
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Published in | Blood Vol. 62; no. 5; pp. 1135 - 1138 |
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Main Authors | , , , , , , , |
Format | Journal Article |
Language | English |
Published |
Washington, DC
Elsevier Inc
01.11.1983
The Americain Society of Hematology |
Subjects | |
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Abstract | 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. |
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AbstractList | 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. Abstract 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. |
Author | Lusher, J.M. Blatt, P.M. White, G.C. Penner, J.A. Levine, P.H. Whitehurst, D.A. Aledort, L.M. Warner, A.I. |
Author_xml | – sequence: 1 givenname: J.M. surname: Lusher fullname: Lusher, J.M. – sequence: 2 givenname: P.M. surname: Blatt fullname: Blatt, P.M. – sequence: 3 givenname: J.A. surname: Penner fullname: Penner, J.A. – sequence: 4 givenname: L.M. surname: Aledort fullname: Aledort, L.M. – sequence: 5 givenname: P.H. surname: Levine fullname: Levine, P.H. – sequence: 6 givenname: G.C. surname: White fullname: White, G.C. – sequence: 7 givenname: A.I. surname: Warner fullname: Warner, A.I. – sequence: 8 givenname: D.A. surname: Whitehurst fullname: Whitehurst, D.A. |
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References | Roberts, White, McMillan, Braunstein, Blatt (bib9) 1982 Dietrich, Luck, Martinson (bib11) 1982 Lusher, Shapiro, Palascak, Rao, Levine, Blatt (bib4) 1980; 303 Roberts (bib12) 1981; 305 Schimpf, Rothman, Zeltsch, Puhl (bib14) 1982 Duthie, Matthews, Rizza, Steel, Woods (bib10) 1972 Gill FM, Shapiro SS, Poole WK, Palascak JE, Hultin MB, Whitehurst DA, Rao AV, the Hemophilia Study Group: The natural history of factor VIII inhibitors in patients with hemophilia A: A national cooperative study. I. Characteristics of the population. Blood (in press) Abildgaard, Penner, Watson-Williams (bib6) 1980; 56 Sjamsoedin, Heisnen, Mauser-Bunschoten, van Geijlswijk, van Houwelinsen, van Asten, Sixma (bib5) 1981; 305 Aronstam, Aston, Wassef, Hamad (bib7) 1980; 2 McMillan CW, Shapiro SS, Whitehurst D, Hoyer LW, Rao AV, Lazerson J, the Hemophilia Study Group: The natural history of factor VIII inhibitors in patients with hemophilia A: A national cooperative study. II. Observations on the initial development of factor VIII inhibitors. Blood (in press) Lusher JM: Unpublished observations Blatt, Menache, Roberts (bib8) 1980; 44 |
References_xml | – volume: 56 start-page: 978 year: 1980 ident: bib6 article-title: Anti-inhibitor coagulant complex (Autoplex) for treatment of factor VIII inhibitors in hemophilia publication-title: Blood contributor: fullname: Watson-Williams – start-page: 101 year: 1972 end-page: 133 ident: bib10 publication-title: The Management of Musculo-skeletal Problems in the Haemophiliac contributor: fullname: Woods – start-page: 39 year: 1982 end-page: 44 ident: bib9 article-title: Current approaches to the treatment of patients with anti-factor VIII antibodies publication-title: Activated Prothrombin Complex Concentrates. Proceedings of Symposium on Activated Prothrombin Complex Concentrates, Rome, 1981 contributor: fullname: Blatt – start-page: 85 year: 1982 end-page: 98 ident: bib11 article-title: Musculoskeletal problems publication-title: Hemophilia in the Child and Adult contributor: fullname: Martinson – start-page: 163 year: 1982 end-page: 164 ident: bib14 article-title: Correction osteotomy of femur in a hemophiliac with an inhibitor to factor VIII publication-title: Activated Prothrombin Complex Concentrates. Proceedings of Symposium on Activated Prothrombin Complex Concentrates, Rome, 1981 contributor: fullname: Puhl – volume: 303 start-page: 421 year: 1980 ident: bib4 article-title: Efficacy of prothrombin complex concentrates in hemophiliacs with antibodies to Factor VIII. A multicenter therapeutic trial publication-title: N Engl J Med contributor: fullname: Blatt – volume: 305 start-page: 717 year: 1981 ident: bib5 article-title: The effect of activated prothrombin complex concentrate (FEIBA) on joint and muscle bleeding in patients with hemophilia A and antibodies to factor VIII. A double-blind clinical trial publication-title: N Engl J Med contributor: fullname: Sixma – volume: 2 start-page: 1294 year: 1980 ident: bib7 article-title: New activated factor IX product in hemophilia publication-title: Lancet contributor: fullname: Hamad – volume: 44 start-page: 39 year: 1980 ident: bib8 article-title: A survey of the effectiveness of prothrombin complex concentrates in controlling hemorrhage in patients with hemophilia and anti-factor VIII antibodies publication-title: Thromb Haemostas contributor: fullname: Roberts – volume: 305 start-page: 757 year: 1981 ident: bib12 article-title: Hemophiliacs with inhibitors: Therapeutic options (editorial) publication-title: N Engl J Med contributor: fullname: Roberts |
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Snippet | In view of uncontrolled observations and anecdotal reports suggesting that the activated PCC, Autoplex, was much more effective than standard (non-activated)... Abstract In view of uncontrolled observations and anecdotal reports suggesting that the activated PCC, Autoplex, was much more effective than standard... |
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SubjectTerms | 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 |
Title | Autoplex Versus Proplex: A Controlled, Double-Blind Study of Effectiveness in Acute Hemarthroses in Hemophiliacs With Inhibitors to Factor VIII |
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