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Clinical study of recovery and half-life of vapor-heated factor VII concentrate. 1994

G E Rivard, and I Kovac, and M Kunschak, and P Thöne
Hematology Service, Ste-Justine Hospital, Montréal, Quebec, Canada.

BACKGROUND The in vivo recovery and half-life of intermediate-purity, vapor-heated factor VII (FVII) concentrate were determined in patients having a congenital deficiency for FVII according to the 1991 guidelines of the International Society for Thrombosis and Haemostasis. METHODS A total of 11 patients received a single infusion of the FVII concentrate. Blood was drawn before infusion and 15 and 30 minutes and 1, 2, 4, 8, 12, and 24 hours after. Recoveries were calculated from the highest FVII activity of the first four blood samples drawn after infusion. The two-phase linear regression method was used to estimate the half-life according to the two-compartment model. In addition, a noncompartmental approach was applied. RESULTS The mean recovery value obtained for FVII concentrate, 110.53 percent (SD, +/- 26.37), indicates rapid and efficient incorporation into the blood stream. Equivalent results were obtained with both pharmacokinetics methods and indicate a very short half-life for FVII. A half-life of 6.49 hours (SD, +/- 2.42) was obtained with the compartmental method and a half-life of 5.25 hours (SD, +/- 2.42) with the noncompartmental method. CONCLUSIONS The half-life and recovery reported here, along with the specificity of the replacement therapy, the earlier anecdotal cases of clinical efficacy, and the clinical safety of the concentrate with regard to viral infections, recommend vapor-heated FVII concentrate for the treatment of patients with hereditary FVII deficiency.

UI MeSH Term Description Entries
D007223 Infant A child between 1 and 23 months of age. Infants
D008297 Male Males
D010827 Physiology The biological science concerned with the life-supporting properties, functions, and processes of living organisms or their parts.
D002648 Child A person 6 to 12 years of age. An individual 2 to 5 years old is CHILD, PRESCHOOL. Children
D002675 Child, Preschool A child between the ages of 2 and 5. Children, Preschool,Preschool Child,Preschool Children
D005167 Factor VII Heat- and storage-stable plasma protein that is activated by tissue thromboplastin to form factor VIIa in the extrinsic pathway of blood coagulation. The activated form then catalyzes the activation of factor X to factor Xa. Coagulation Factor VII,Proconvertin,Stable Factor,Blood Coagulation Factor VII,Factor 7,Factor Seven,Factor VII, Coagulation
D005168 Factor VII Deficiency An autosomal recessive characteristic or a coagulation disorder acquired in association with VITAMIN K DEFICIENCY. FACTOR VII is a Vitamin K dependent glycoprotein essential to the extrinsic pathway of coagulation. Hypoproconvertinemia,Deficiency, Factor 7,Deficiency, Factor Seven,Deficiency, Factor VII,Factor 7 Deficiency,Deficiencies, Factor 7,Deficiencies, Factor Seven,Deficiencies, Factor VII,Factor 7 Deficiencies,Factor Seven Deficiencies,Factor Seven Deficiency,Factor VII Deficiencies,Hypoproconvertinemias
D005260 Female Females
D006207 Half-Life The time it takes for a substance (drug, radioactive nuclide, or other) to lose half of its pharmacologic, physiologic, or radiologic activity. Halflife,Half Life,Half-Lifes,Halflifes
D006358 Hot Temperature Presence of warmth or heat or a temperature notably higher than an accustomed norm. Heat,Hot Temperatures,Temperature, Hot,Temperatures, Hot

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