Anti-inhibitor Coagulant Complex Research Articles

Seventeen years' experience with Autoplex/Autoplex T: evaluation of inpatients with severe haemophilia A and factor VIII inhibitors at a major haemophilia centre.

A retrospective case analysis of the use of Autoplex T (anti-inhibitor coagulant complex [heat treated]) at a major haemophilia treatment centre is described. Twenty-three haemophilia A patients with a history of high-titre (>10 BU), high-response inhibitors were treated for a total of 54 bleeding episodes requiring hospital admission and/or surgical intervention. Effective or partially effective haemostatic control was achieved within 72 h in 94% of reported cases (effective 85%; partially effective 9%). The incidence of adverse reactions was low and there were no thrombotic complications. In bleeding episodes for which BU titres were determined within 6 months pre- and 6 months post-treatment, there was little tendency for Autoplex T to cause an anamnestic response (1 of 19 bleeding episodes). In the three invasive surgical procedures included in the case review, coverage with Autoplex T resulted in no postoperative complications, no bleeding at the surgical site, and no postoperative haematoma. The results support the efficacy and safety of Autoplex T in the treatment of bleeding episodes and haemostatic coverage of surgical procedures in haemophilia A patients with inhibitors.

Viral Safety of Clotting Factor Concentrates

The efforts to reduce the risk of viral disease due to clotting factor concentrates have been quite successful. However, additional steps need to be taken to protect the users of these products. First, all patients should be vaccinated against hepatitis B. Second, vaccines against other viruses need to be developed. There is a great deal of interest in an HIV vaccine, and a vaccine against hepatitis C would also be a great boon to the "at risk" population. Third, more effective inactivation procedures need to be implemented in the manufacturing of concentrates other than Factor VIII, including Factor IX Complex, Coagulation Factor IX (Human), and Anti-Inhibitor Coagulant Complex. Despite the advances that have been made, it should be remembered that none of these procedures is perfect and the risk will never be reduced to zero. This is because the plasma pools will always contain infectious virus and the manufacturing process, regardless of how carefully controlled, cannot be made fail-safe. Errors will be made that result in contamination or inadequate treatment of products. For this reason, strict adherence to standard operating procedures and good manufacturing practices is essential. The investments of time, money, and hard work that have been made toward improving the safety of clotting factor concentrates have yielded a handsome return thus far. It is hoped that continued efforts in this direction will result in even greater benefits.

Efficacy and safety of vapor‐heated anti‐inhibitor coagulant complex in hemophilia patients. FEIBA Study Group

The study reported here was designed to measure the efficacy and safety of a vapor-heated anti-inhibitor coagulant complex (FEIBA-VH) for the treatment of bleeding episodes in patients with hemophilia A who have inhibitors to factor VIII (FVIII). FEIBA-VH, a second-generation complex, is vapor-heated for 10 hours at a temperature of 60 degrees C and a pressure of 1190 millibar (mbar) and for 1 additional hour at 80 degrees C and 1375 mbar. The current study was performed because of concern that this vapor-heating process would reduce the efficacy of FEIBA-VH as compared with non-heat-treated FEIBA (FEIBA). Forty-one patients received FEIBA-VH for 106 evaluable bleeding episodes. Ninety-three (88%) episodes were controlled, and 13 (12%) were not. Eighty-three (79%) episodes were controlled within 36 hours of the first infusion. No significant toxicity was seen. These results were compared with those of an earlier study with FEIBA. FEIBA-VH was at least as effective as FEIBA in controlling bleeding episodes and can be compared favorably to any reported treatment of bleeding episodes in hemophiliacs with inhibitors to FVIII.

Heat inactivation of human immunodeficiency virus in lyophilized anti-inhibitor coagulant complex (autoplex®)

Heat inactivation of human immunodeficiency virus in lyophilized anti-inhibitor coagulant complex (autoplex®)

Failure of Activated Prothrombin Complex Concentrates in a Hemophiliac With an Anti-Factor VIII Antibody

IN APPROXIMATELY 15% of patients with severe hemophilia A who receive multiple transfusions, anti— factor VIII antibodies develop (C. W. McMillan, MD, S. S. Shapiro, MD, J. Lazerson, MD, unpublished data, 1983). Control of hemorrhagic episodes in these patients is often difficult and unsatisfactory. Various methods of treatment have been developed for such patients.^1,2Most recently, activated prothrombin complex concentrates (PCCs) have been described as efficacious in controlling hemorrhage in patients with an inhibitor. Two preparations of activated PCC have been developed: Autoplex (anti-inhibitor coagulant complex) and FEIBA (factor eight inhibitor bypassing activity). In published trials, response to treatment with Autoplex for major and minor bleeds ranged from excellent to fair with no treatment failures,²while FEIBA was judged to be effective in control of joint and muscle bleeding in 64% of treatment episodes.³The purpose of this report is to describe the failure of Autoplex to

Prothrombin Complex Concentrates and Inhibitors

The management of hemorrhages in patients with strong inhibitors to factor VIII continues to challenge our ingenuity. No therapy stops all hemorrhages in all patients. We live with the possibility of uncontrollable bleeding. New treatment modalities are welcomed with eager hopefulness. Prothrombin complex concentrates (PCCs), usually used to treat hemophilia B (factor IX deficiency), shorten the partial thromboplastin time when added in vitro to plasma containing inhibitor to factor VIII. On the basis of this observation, PCCs were first tried in patients with critical hemorrhages in the early 1970s, with dramatic success in several instances. Purposely activated PCCs—including Autoplex, United States, and FEIBA, Austria (anti-inhibitor coagulant complex)—have a greater ability in vitro to bypass the need for factor VIII than ordinary PCCs, such as Konȳne or Proplex (factor IX complex), but all PCC products have been used extensively in patients with inhibitors. Evaluation of the efficacy of PCCs is difficult.

Anti-inhibitor Coagulant Complex (Autoplex) in Hemophilia Inhibitor Patients Undergoing Synovectomy

Surgical synovectomy employed in the management of hemophilic arthropathy has been contraindicated in patients with inhibitors because of potential difficulties in achieving hemostasis. However, the development of activated prothrombin-complex concentrates has improved the management of hemophiliacs with inhibitors, particularly those with high levels of inhibitor for whom other treatment modalities are of minimal benefit. With the use of one of these activated products, Autoplex, surgical procedures have been successfully accomplished in hemophiliacs with inhibitors. Two inhibitor patients who each had severe arthropathy of one knee underwent elective surgical synovectomy while being treated with Autoplex. Hemostasis was achieved during the perioperative period in both patients. Neither patient exhibited clinical signs of suggestive of consumptive coagulopathy or thrombosis, side effects potentially associated with the use of activated prothrombin-complex concentrates.

Potency Determination of Anti-Inhibitor Coagulant Complex – Autoplex

Potency Determination of Anti-Inhibitor Coagulant Complex – Autoplex

Anti-Inhibitor Coagulant Complex (Autoplex) for Treatment of Factor VIII Inhibitors in Hemophilia

Abstract Fourteen individuals with severe hemophilia complicated by factor VIII inhibitors (1 to 132 Bethesda Units) were treated for 33 bleeding episodes with a new activated prothrombin complex concentrate, Anti- Inhibitor Coagulant Complex (Autoplex, Hyland, Glendale, Calif.). Excellent or good results were observed in 21 of 25 minor bleeding episodes treated, which included joint, soft tissue, and mucous membrane hemorrhages. Eight major bleeding problems (an epidural bleed, a puncture wound, 2 serious soft tissue hemorrhages, 2 lacerations, and 2 major surgical procedures) were treated with excellent (6) or good (2) results. No serious complications were encountered, but two children developed transient hypofibrinogenemia following Autoplex infusion. Although some shortening of the prothrombin time and activated partial thromboplastin time was noted after infusion of Autoplex, there is no useful laboratory test for monitoring therapy. Despite the unknown mechanism of action for bypassing factor VIII, Autoplex appears to be a useful and needed interim product and is safe and effective. In view of the possible potentiation of thrombosis concurrent use of fibrinolytic inhibitors should be avoided.

Anti-inhibitor Coagulant Complex (Autoplex) for treatment of factor VIII inhibitors in hemophilia

Fourteen individuals with severe hemophilia complicated by factor VIII inhibitors (1 to 132 Bethesda Units) were treated for 33 bleeding episodes with a new activated prothrombin complex concentrate, Anti-Inhibitor Coagulant Complex (Autoplex, Hyland, Glendale, Calif.). Excellent or good results were observed in 21 of 25 minor bleeding episodes treated, which included joint, soft tissue, and mucous membrane hemorrhages. Eight major bleeding problems (an epidural bleed, a puncture wound, 2 serious soft tissue hemorrhages, 2 lacerations, and 2 major surgical procedures) were treated with excellent (6) or good (2) results. No serious complications were encountered, but two children developed transient hypofibrinogenemia following Autoplex infusion. Although some shortening of the prothrombin time and activated partial thromboplastin time was noted after infusion of Autoplex, there is no useful laboratory test for monitoring therapy. Despite the unknown mechanism of action for bypassing factor VIII, Autoplex appears to be a useful and needed interim product and is safe and effective. In view of the possible potentiation of thrombosis concurrent use of fibrinolytic inhibitors should be avoided.