Continuous infusion of recombinant factor VIIa for surgery in patients with deficiency of factor VII

2005 ◽  
Vol 94 (12) ◽  
pp. 1177-1180 ◽  
Author(s):  
Geir E. Tjønnfjord ◽  
Richard Wallensten ◽  
Uri Martinowitz ◽  
Gili Kenet ◽  
Sam Schulman
Keyword(s):  
Continuous Infusion ◽  
Recombinant Factor Viia ◽  
Factor Viia ◽  
Single Case ◽  
Thromboembolic Complication ◽  
Factor Vii ◽  
Recombinant Activated Factor Vii ◽  
Activated Factor Vii ◽  
Different Types ◽  
Fvii Deficiency

SummaryThe administration of recombinant activated factor VII (rFVIIa) by continuous infusion has provided a safe and convenient alternative to bolus injections in haemophiliacs with inhibitors, but it has only been reported in a single case with congenital factorVII (FVII) deficiency. The results of 12 consecutive surgical procedures in 7 patients with congenital FVII deficiency are reported here. rFVIIa was always given in continuous infusion, aiming at plasma FVII activity of 0.5 IU/mL. Treatment was given for 2 to 7 days with a mean total dose of 7.8 mg rFVIIa. Blood loss was as expected from the different types of procedures and the only thromboembolic complication was a superficial thrombophlebitis at the infusion site. This mode of substitution was therefore safe, effective and well tolerated.

Recombinant factor VIIa

2005 ◽  
Vol 93 (06) ◽  
pp. 1027-1035 ◽  
Author(s):  
Marco Zaffanello ◽  
Dino Veneri ◽  
Massimo Franchini
Keyword(s):  
Recombinant Factor Viia ◽  
Factor Viia ◽  
Current Knowledge ◽  
Coagulation Factors ◽  
Factor Vii ◽  
Recombinant Activated Factor Vii ◽  
Activated Factor Vii ◽  
Viii And Ix ◽  
Bleeding Episodes ◽  
Uncontrolled Bleeding

SummaryRecombinant activated factor VII (rFVIIa, Novo Seven®) has been successfully used to treat bleeding episodes in patients with antibodies against coagulation factors VIII and IX. In recent years, rFVIIa has also been employed for the management of uncontrolled bleeding in a number of congenital and acquired haemos- tatic abnormalities. Based on a literature search, this review examines the current knowledge on therapy with rFVIIa, from the now well-standardized uses to the newer and less well-characterised clinical applications.

Recombinant Factor VIIa Is Effective for Bleeding and Surgery in Patients With Glanzmann Thrombasthenia

Blood ◽  
1999 ◽  
Vol 94 (11) ◽  
pp. 3951-3953 ◽  
Author(s):  
Man-Chiu Poon ◽  
Christine Demers ◽  
François Jobin ◽  
John W.Y. Wu
Keyword(s):  
Platelet Transfusion ◽  
Recombinant Factor Viia ◽  
Factor Viia ◽  
Factor Vii ◽  
Recombinant Activated Factor Vii ◽  
Glanzmann Thrombasthenia ◽  
Activated Factor Vii ◽  
Number Of Patients ◽  
Antifibrinolytic Drugs ◽  
Bleeding Episodes

Recombinant activated factor VII (rFVIIa) was found to be effective and safe in treating 24 bleeding episodes and to prevent bleeding during one bilateral herniorrhaphy in four children with Glanzmann thrombasthenia. One of the patients had alloantibodies to platelet membrane glycoprotein (GP) IIb/IIIa and was refractory to platelet transfusion. rFVIIa was administered at 89 to 116 μg/kg per injection every 2 hours, in association with antifibrinolytic drugs. Bleeding stopped in all cases, but platelet transfusion was required in one. Two bleeding episodes recurred 36 and 63 hours after discontinuation of rFVIIa, but were successfully treated with additional doses. No adverse effects of rFVIIa were observed. Although the number of patients is small, our study suggests that rFVIIa may be an alternative to platelet transfusions in patients with a severe congenital thrombocytopathy.

Use of recombinant factor VIIa in the perioperative period

2009 ◽  
Vol 29 (01) ◽  
pp. 68-70 ◽  
Author(s):  
M. Levi
Keyword(s):  
Blood Loss ◽  
Recombinant Factor Viia ◽  
Factor Viia ◽  
Coagulation Factor ◽  
Perioperative Period ◽  
Factor Vii ◽  
Clinical Settings ◽  
Recombinant Activated Factor Vii ◽  
Activated Factor Vii ◽  
Life Threatening

SummaryRecombinant activated factor VII (rFVIIa) is a pro-haemo -static agent that can be used for patients with haemophilia and inhibiting antibodies towards a coagulation factor. Recombinant factor VIIa is, however, increasingly used for several other indications, including patients who experience serious and life-threatening bleeding. In addition, rFVIIa has been evaluated for the prevention of major blood loss in patients undergoing surgical procedures that are known to be associated with major blood loss. In this manuscript we review the data on efficacy and safety of rFVIIa in the prevention of excessive blood loss and trans-fusion requirements in the perioperative period.We conclude that recombinant factor VIIa is a promising agent for perioperative prevention of major blood loss but that its efficacy will probably vary between specific clinical settings. Its exact place in surgery warrants further clinical trials in various situations that will also more precisely determine the safety of this intervention.

Recombinant Factor VIIa Is Effective for Bleeding and Surgery in Patients With Glanzmann Thrombasthenia

Blood ◽  
1999 ◽  
Vol 94 (11) ◽  
pp. 3951-3953 ◽  
Author(s):  
Man-Chiu Poon ◽  
Christine Demers ◽  
François Jobin ◽  
John W.Y. Wu
Keyword(s):  
Platelet Transfusion ◽  
Recombinant Factor Viia ◽  
Factor Viia ◽  
Factor Vii ◽  
Recombinant Activated Factor Vii ◽  
Glanzmann Thrombasthenia ◽  
Activated Factor Vii ◽  
Number Of Patients ◽  
Antifibrinolytic Drugs ◽  
Bleeding Episodes

Abstract Recombinant activated factor VII (rFVIIa) was found to be effective and safe in treating 24 bleeding episodes and to prevent bleeding during one bilateral herniorrhaphy in four children with Glanzmann thrombasthenia. One of the patients had alloantibodies to platelet membrane glycoprotein (GP) IIb/IIIa and was refractory to platelet transfusion. rFVIIa was administered at 89 to 116 μg/kg per injection every 2 hours, in association with antifibrinolytic drugs. Bleeding stopped in all cases, but platelet transfusion was required in one. Two bleeding episodes recurred 36 and 63 hours after discontinuation of rFVIIa, but were successfully treated with additional doses. No adverse effects of rFVIIa were observed. Although the number of patients is small, our study suggests that rFVIIa may be an alternative to platelet transfusions in patients with a severe congenital thrombocytopathy.

Population Pharmacokinetics of Recombinant Factor VIIa in Volunteers Anticoagulated with Acenocoumarol

1998 ◽  
Vol 80 (07) ◽  
pp. 109-113 ◽  
Author(s):  
Patrice Nony ◽  
Elisabeth Erhardtsen ◽  
Sylvie Delair ◽  
Patrick Ffrench ◽  
Marc Dechavanne ◽  
...  
Keyword(s):  
Factor Viia ◽  
Compartment Model ◽  
Volume Of Distribution ◽  
Individual Variability ◽  
Factor Vii ◽  
Recombinant Activated Factor Vii ◽  
Activated Factor Vii ◽  
Dose Ranging ◽  
Endogenous Activity ◽  
Dose Dependent

SummaryThis study establishes a population PK model for FVII clotting activity (FVII:C) after injection of recombinant activated factor VII (rFVIIa) to healthy volunteers. Twenty eight volunteers, anticoagulated with acenocoumarol, received one or two rFVIIa injections, with dose ranging from 5 to 320 μg/kg. The FVII:C kinetic was fitted to a 2 compartment model, with continuous “endogenous perfusion” mimicking endogenous activity. Estimated clearance was 2.4 l/h (20% inter-individual variability and 9% inter-period variability). The volume of distribution at steady-state appeared to be significantly dose dependent: 78 ml/kg for doses ≤20 μg/kg and 88 ml/kg for doses >20 μg/kg respectively, with 16% inter-individual variability. The dose producing 50% of the maximum drop of INR was estimated to be 2.2 μg/kg. The model will be used to better define the dosage regimen for future clinical developments.

scholarly journals Congenital Deficiency in Factor VII Revealed by Menorrhagia: Case Report

2020 ◽  
pp. 1-5
Author(s):  
Nadia Mebrouk ◽  
Abdelilah Radi ◽  
Mohamed Selouti ◽  
Amal Hassani ◽  
Abdelhakim Ourrai ◽  
...  
Keyword(s):  
Treatment Options ◽  
Specific Treatment ◽  
Fresh Frozen Plasma ◽  
Factor Vii ◽  
Activity Measurement ◽  
Recombinant Activated Factor Vii ◽  
Congenital Deficiency ◽  
Activated Factor Vii ◽  
Fresh Frozen ◽  
Fvii Deficiency

Factor VII (FVII) deficiency is the most common among rare inherited autosomal recessive bleeding disorders. It is a multifaceted disease because of the lack of a direct correlation between plasma levels of coagulation FVII and bleeding manifestations. Clinical phenotypes range from asymptomatic condition—even in homozygous subjects—to severe, life-threatening bleedings (e.g., central nervous system and gastrointestinal bleeding). Menorrhagia is a frequent type of bleeding in FVII deficiency, with a prevalence rate of two in three women aged 10 to 50 years and with a peak prevalence in teenagers. When menorrhagia is observed and once the gynecological causes are excluded, it is important to carry out a hemostasis assessment because, if an anomaly is found, specific treatment can be administered and preventive measures taken. Basic diagnostic work-up includes routine assays, prothrombin level, activated partial thromboplastin time and platelet count, followed by FVII coagulant activity measurement for isolated decreased prothrombin level. To confirm the diagnosis, FVII assay should be repeated at least once. Several treatment options are currently available for FVII deficiency: Recombinant activated Factor VII (rFVIIa), plasma-derived Factor VII, fresh frozen plasma and prothrombin complex concentrates. rFVIIa is the most used replacement therapy. Other medical therapies of menorrhagia includes hemostatic agents and hormonal treatments (combined oral contraceptives, levonorgestrel intrauterine devices), in combination or not with rFVIIa. We report the case of a fourteen-and-a-half-year-old girl who presented menorrhagia of great abundance at the age of thirteen, the exploration of which revealed a congenital deficit in FVII.

Redistribution of Recombinant Activated Factor VIIA into Platelets and Vascular Bed: Implications on Bioavailability and Hemostatic Mechanisms.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 3957-3957
Author(s):  
Ana Maria Galan ◽  
Irene Lopez-Vilchez ◽  
Juan Gracia ◽  
Gines Escolar
Keyword(s):  
Flow Cytometry ◽  
Cross Sections ◽  
Factor Viia ◽  
Platelet Rich Plasma ◽  
Thrombus Formation ◽  
Factor Vii ◽  
Recombinant Activated Factor Vii ◽  
Activated Factor Vii ◽  
Perfusion Studies ◽  
Subendothelial Matrix

Abstract Background: Clinical evidence suggests that hemostatic action of recombinant activated factor VII (rFVIIa) exceeds its predicted plasma half life (around 3 hours). Mechanisms involved in the long lasting effects of rFVIIa for prophylactic treatment of patients with hemophilia and inhibitors have not been fully elucidated. Previous studies from our group have demonstrated that platelets internalize tissue factor preparations containing small amounts of FVII. We have investigated the possible redistribution of rFVIIa in different intracellular compartments focussing more specifically on platelets, endothelium and subendothelial matrix. Methods: We exposed platelet rich plasma, isolated platelets, human umbilical veins and endothelial cells in culture (HUVECs) to rFVIIa. Samples were incubated for up to 2 hours at rFVIIa concentrations from 2-60 mg/ml (normal plasma concentration: 0.5 mg/ml). Flow cytometry techniques were applied to detect surface and intracellular antigens, including FVIIa, in platelets before and after exposure to membrane permeabilizing agents. Immunocytochemical techniques were applied to detect FVIIa in cross sections of umbilical veins and confocal microscopy was used to detect FVIIa in HUVECs. In additional studies, aliquots of washed platelets previously exposed to rFVIIa were incorporated into whole blood anticoagulated with low molecular weight heparin (LMWH) and perfused through a collagen rich damaged vascular surface at a shear rate equivalent to 600/sec. Results: Flow cytometry studies revealed a significantly enhanced presence of intracellular FVIIa in platelets previously exposed to rFVIIa. Fluorescence intensity related to FVIIa was dependent on the concentration of rFVIIa used during the incubation. A more intense labeling for FVIIa was observed in the subendothelial matrix of umbilical veins exposed to rFVIIa. In perfusion studies, presence of platelets previously exposed to rFVIIa improved platelet thrombus formation and enhanced fibrin generation with respect to parallel experiments using platelets not exposed to rFVIIa. Conclusion: Our results indicate that rFVIIa can be internalized into platelets and redistributed into subendothelial compartments. Redistribution of rFVIIa into other cellular compartments may explain the prolonged prophylactic action of rFVIIa in some clinical conditions. The existence of extravascular sources of FVIIa may provide new insights into the physiological and pathological implications of FVIIa on hemostasis mechanisms.

Recombinant Factor VIIa for the Prophylaxis of Perioperative Hemorrhage in a Patient With Congenital Factor XI Deficiency Undergoing Brain Tumor Neurosurgery

2007 ◽  
Vol 14 (4) ◽  
pp. 472-475 ◽  
Author(s):  
Christoph Sucker ◽  
Michael Sabel ◽  
Walter Stummer ◽  
Rainer B. Zotz ◽  
Ruediger E. Scharf ◽  
...  
Keyword(s):  
Brain Tumor ◽  
Factor Viia ◽  
Factor Vii ◽  
Bleeding Complications ◽  
Factor Xi ◽  
Recombinant Activated Factor Vii ◽  
Promising Alternative ◽  
Factor Xi Deficiency ◽  
Activated Factor Vii ◽  
Perioperative Hemorrhage

The authors report on the first successful use of recombinant activated factor VII for the prophylaxis of bleeding during brain tumor neurosurgery in a patient suffering from inherited factor XI deficiency. Using the agent, surgery was performed without any bleeding complications. In this setting, off-label use of recombinant activated factor VII appears to be a promising alternative for patients suffering from this rare hemostatic defect with hitherto limited therapeutic options.

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