Pharmacokinetic study of minipooled solvent/detergent-filtered cryoprecipitate factor VIII

Magdy El-Ekiaby, Hadi Alphonse Goubran, M. Radosevich, A. Abd-Allah, A. El-Ekiaby, Thierry Pierre Robert Burnouf

Research output: Contribution to journalArticle

9 Citations (Scopus)

Abstract

Eighteen cryoprecipitate minipools, each made of 30units of low volume, concentrated cryoprecipitate, have been treated by solvent-detergent and filtration (S/D-F) in a single-use CE-marked bag system. The S/D-F cryoprecipitate contained a mean of 10.5IUmL -1 factor VIII (FVIII), 17mgmL -1 clottable fibrinogen, and >10IUmL -1 von Willebrand factor ristocetin co-factor, and anti-A and anti-B isoagglutinins were undetectable. The products have been infused in 11 severe (FVIII -1. Patients were hospitalized for at least 36h to determine FVIII recovery, half-life and clearance. They were also closely monitored for possible adverse events. None of the infused patients demonstrated reactions or adverse events even though they did not receive anti-allergic drugs or corticosteroids prior to infusion. The mean recovery of FVIII 10min postinfusion was 69.7%. Mean FVIII half-life was 14.2h and clearance was 2.6mLh -1kg -1. All patients had a bleeding-free interval of 8-10days postS/D-F cryoprecipitate infusion. The data show that S/D-F cryoprecipitate FVIII presents a normal pharmacokinetics profile, and support that it could be safely used for the control of acute and chronic bleeding episodes in haemophilia A patients.

Original languageEnglish
JournalHaemophilia
Volume17
Issue number5
DOIs
Publication statusPublished - Sep 2011

Fingerprint

Factor VIII
Detergents
Pharmacokinetics
Half-Life
Ristocetin
Hemorrhage
Anti-Allergic Agents
Hemophilia A
von Willebrand Factor
Fibrinogen
Adrenal Cortex Hormones
Pharmaceutical Preparations

Keywords

  • Cryoprecipitate
  • Factor VIII
  • Half-life
  • Minipool
  • Recovery
  • Solvent-detergent

ASJC Scopus subject areas

  • Hematology
  • Genetics(clinical)

Cite this

Pharmacokinetic study of minipooled solvent/detergent-filtered cryoprecipitate factor VIII. / El-Ekiaby, Magdy; Goubran, Hadi Alphonse; Radosevich, M.; Abd-Allah, A.; El-Ekiaby, A.; Burnouf, Thierry Pierre Robert.

In: Haemophilia, Vol. 17, No. 5, 09.2011.

Research output: Contribution to journalArticle

El-Ekiaby, Magdy ; Goubran, Hadi Alphonse ; Radosevich, M. ; Abd-Allah, A. ; El-Ekiaby, A. ; Burnouf, Thierry Pierre Robert. / Pharmacokinetic study of minipooled solvent/detergent-filtered cryoprecipitate factor VIII. In: Haemophilia. 2011 ; Vol. 17, No. 5.
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