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At least 163 records · Page 9Linked to original sources
PubMed1982

Blood products used in the treatment of hemophilia.

The treatment of the hemophilias is a great challenge to all clinicians involved in the care of hemophiliacs. The proper use of blood products, such as whole blood, plasma, fresh frozen plasma, cryoprecipitated factor VIII, commercial factor VIII concentrate, prothrombin complex concentrate, and anti-inhibitor coagulant complex, has a significant effect on the quality of care that these patients receive. Manufacturers now have the ability to commercially prepare some of these products as dry powders requiring reconstitution prior to use. This capability has enabled the department of pharmacy to store, and the pharmacist to dispense, such products as commercial factor VIII concentrate, prothrombin complex concentrate, and anti-inhibitor coagulant complex when needed. Consequently, the practicing pharmacist should possess a basic understanding of how and when the different blood products are used in the treatment of hemophilia. A review of these blood products is presented.

Factor VIII↗
PubMed1999

Clinical efficacy of prothrombin complex concentrates and recombinant factor VIIa in the treatment of bleeding episodes in patients with factor VII and IX inhibitors.

An overview is given on APCCs and recombinant FVIIa for the treatment of bleeding episodes in hemophiliacs with FVIII or FIX inhibitors or in patients with acquired hemophilia. The initial dose of activated plasma-derived PPCs, mainly FEIBA, is up to 100 U/kg body weight, and the maintenance dosage is up to 100 U/kg body weight twice daily. The single dosage of recombinant FVIIa is about 60-90 microg/kg body weight, which has to be repeated every 2 to 6 hours depending on the bleeding situation.

Blood Coagulation Factors↗
PubMed1976

Various prothrombin complex concentrates and their effect on coagulation and fibrinolysis in vivo.

Thromboembolic complications occurring in patients treated with factor IX concentrates have been reported. To study the thrombogenicity various types of factor IX concentrates (50 or 100 units F. IX/kg bodyweight) have been infused in dogs. As control albumin was given. The various components of the coagulation and fibrinolytic system have been assayed before the infusion and at various intervals after the end of infusion (0, 1, 4 and 24 hrs). Konyne resulted in marked activation of the coagulation process with decrease of platelets, fibrinogen, F. VIII and appearance of FDP and positive ethanol gelation test. Prothromplex and Preconativ gave no significant changes. Preconativ is prepared without addition of heparin during the procedure.

Animals↗
PubMed1994

Use of prothrombin complex concentrates in management of bleeding in hemophiliacs with inhibitors--benefits and limitations.

In summary, PCCs and APCCs are moderately effective in controlling bleeding in inhibitor patients. However, they are not as effective in controlling or preventing bleeding as factor VIII (or factor IX) concentrates in hemophiliacs who do not have inhibitors. Their precise mechanism of action is still poorly understood, and there is no readily available laboratory test for monitoring patient response. While viral safety is far less of an issue with PCCs than it was a few years ago, and while thrombogenicity is far less of a problem in using PCCs and APCCs in inhibitor patients than it is in persons with hemophilia B, one must keep in mind the risk of acute myocardial infarction. Frequent, repetitive doses may be hazardous. PCCs and APCCs represent a valuable part of one's therapeutic armamentarium in managing bleeding in inhibitor patients. However, one must be aware of their limitations and potential complications, and use them appropriately.

Controlled Clinical Trials as Topic↗
PubMed2006

A direct thrombin inhibitor studied by dynamic whole blood clot formation. Haemostatic response to ex-vivo addition of recombinant factor VIIa or activated prothrombin complex concentrate.

Direct thrombin inhibitors have proven efficacious in prevention of venous thromboembolism. Bleeding complications are rare, but in case of acute serious bleeding, an effective and instant haemostatic intervention may be required. In the present study it was demonstrated that the direct thrombin inhibitor melagatran induces dose-dependent abnormalities in whole blood (WB) clotting profiles as recorded by a recently described modified thrombelastographic model, and that rFVIIa or APCC are capable of improving the haemostatic capacity. Experiments were performed using WB from 30 healthy males. In-vitro titration experiments (n = 10) with addition of melagatran to WB corresponding to plasma concentrations ranging from 0 to 5.0 microM (12 steps) showed a dose-dependent prolongation of the clot initiation and characteristic decrease of the maximum rate of clot propagation. In-vitro intervention studies (n = 20) were completed with four different concentrations of melagatran as well as addition of four different levels of rFVIIa or APCC. At all tested concentrations of melagatran, rFVIIa significantly shortened the melagatran-induced prolonged clot initiation but induced only minor improvements of the reduced clot propagation. In contrast, APCC significantly and dose-dependently shortened the clot initiation and accelerated the clot propagation. In conclusion, our thrombelastographic model appears useful for evaluating the effect of direct thrombin inhibitors on dynamicWB clot formation and rFVIIa, but especially APCC significantly improved theWB clot formation. The pronounced stabilizing effect of APCC may be caused by its content of prothrombin and activated coagulation factors.

Adult↗
PubMed1999

Virus safety of prothrombin complex concentrates and factor IX concentrates.

Substantial progress in virus safety has been achieved during the past 15 years. Therefore only a few virus transmissions with plasma-derived products have been observed since 1985. Specific steps to eliminate, remove, or inactivate viruses were developed. Although virus safety is of decisive importance, chemical or physical treatment during the manufacturing process need not activate labile coagulation factors that cause the risk of thrombogenicity nor need not create neoantigens that mediate the risk of inhibitor formation. Thus, any new virus elimination procedure has to be evaluated and validated for all safety aspects. A comprehensive framework of regulations and efforts has been set up involving plasma donors, donation centres, manufacturers, regulatory authorities, politicians responsible for legislation, physicians, and patients. Blood and plasma donation centres and pharmaceutic industry follow "Good Manufacturing Practice" and are subject to regular audits and official inspections. Every single donation as well as plasma pools are tested for virus markers. The final products need both a marketing authorization and official batch release; in Germany, supervised by the Paul-Ehrlich-Institute. European integration is the purpose of the European Medicines Evaluation Agency. An alert pharmacovigilance system enables scientifically adequate reactions in any case of a safety problem. The ultimate evidence of product safety is provided by clinical surveillance. By participating in clinical studies, patients themselves are able to contribute significantly to the safety of plasma-derived products. The currently achieved high level of safety should encourage us to take further steps to stabilize this success and to look for further progress, wherever possible.

Blood Coagulation Factors↗
PubMed1999

Production and composition of prothrombin complex concentrates: correlation between composition and therapeutic efficiency.

Four-factor PCCs are most frequently used for replacement of vitamin K-dependent clotting factors and inhibitors proteins C and S in patients bleeding after phenprocoumon or warfarin overdose, in vitamin K-deficient patients presenting life-threatening bleeding, and liver disease. Since many of these patients are prone to thromboembolic complications including DIC, all conceivable measures should be taken against the thrombogenic potential of PCC preparations. This thrombogenic potential of PCCs is obviously dependent on several factors including activated clotting factors, lack of inhibitors of blood coagulation, and coagulation factor overload, as well as predisposing factors referred to recipients and drug interactions. The composition of PCC should meet the following criteria: Antithrombin in addition to heparin for the neutralization of FIXa and FXa should be present in the preparations; no overloading with FII and FX; substantially lower FVII than FIX potencies in order to minimize contamination with or generation of FVIIa; and substantial protein C as well as protein S activities. Quality control should include determinations as recommended by the European Pharmacopoeia. Specific assays for quantification of FIXa and FXa are urgently required, and validity of these assays must be proven in surveys. All lots should also be tested for their FVIIa content. Furthermore, the safety of PCCs must be proven by suitable animal models. Whenever possible, patients receiving PCCs should be under low-dose heparin prophylaxis; simultaneous administration of heparin-neutralizing drugs or antifibrinolytic agents must be avoided.

Blood Coagulation Factors↗
PubMed1993

Pharmacokinetics, thrombogenicity and safety of a double-treated prothrombin complex concentrate.

The pharmacokinetic profile, the thrombogenicity and the virus safety of Preconativ, a PCC subjected both to virus removal procedure and dry-heat treatment were studied. Preconativ is produced from plasma pool, negative both for HBsAg and for antibodies to HIV. To further reduce the risk of virus transmission, the manufacturing process includes hydrophobic gel chromatography and dry-heat treatment at +68 degrees C for 48 hours. Nine patients with hemophilia B participated in a single dose, pharmacokinetic study. The decay curves of factor IX clotting activity were evaluated by model-independent methods. The Clearance and the Mean Residence Time were very similar to those previously reported for untreated PCC. The Volume of Distribution Area and In Vivo Recovery resulted inversely correlated and respectively larger and smaller than those of untreated PCC. A slight fall in platelet count and Antithrombin III level and an increase of Beta-Thromboglobulin and Fibrinopeptide A concentration were found, indicating a clear-cut activation of the coagulation process during the first hours following Preconativ administration. Seven patients (2 of the ones enrolled in the pharmacokinetic study) were completely fulfilling the SSC-ISTH criteria for virus safety prospective study. The follow up of these patients did not show any transaminases elevation or seroconversion against HBV, HCV or HIV. These findings did not change over a 3-5 year follow up in 3 out of 7 patients, repeatedly infused with Preconativ.

Adolescent↗