Successful treatment of patients with von Willebrand disease using a high-purity double-virus inactivated factor VIII/von Willebrand factor concentrate (Immunate).

Abstract

Fourteen patients with different types of von Willebrand disease (vWD) having acute bleeds or elective surgery were treated with Immunate(sound recording copyright sign), a double-virus inactivated factor VIII/von Willebrand factor (FVIII/vWF) concentrate. The concentrate was applied as a bolus or via continuous infusion. FVIII activity (FVIIIc), vWF antigen (vWF:Ag), ristocetin cofactor activity (vWF:RCo), collagen binding activity (vWF:CB), activated partial thromboplastin time (aPTT), and von Willebrand multimers (vW-multimers) were monitored for 48 hours. Pharmacokinetic analyses were performed. The clinical efficacy was rated excellent or good. Bleeding complications occurred in 3 patients due to an additional FXIII deficiency in one patient, to a surgically induced bleed in another patient, and a rather short substitution period in the third patient. There were no serious adverse experiences. One patient showed a phlebitic reaction at the site of venous access after more than 100 hours of continuous infusion, requiring a change to application via bolus.

• Authors: Günter Auerswald, Bruno Eberspächer, Werner Engl, Christiane Güthner, Marie Koksch, Wolfhart Kreuz, Antje Nimtz, Gerhard Pindur, Horst Scheel, Jörg D Schreiber, Jürgen Siekmann, Peter L Turecek, Hans-Heinrich Wolf
• Journal: Seminars in thrombosis and hemostasis (Semin Thromb Hemost) Vol. 28 Issue 2 Pg. 203-14 (Apr 2002) ISSN: 0094-6176 [Print] United States
• PMID: 11992243 (Publication Type: Clinical Trial, Clinical Trial, Phase III, Journal Article)

Chemical References

• Drug Combinations
• von Willebrand Factor
• Factor VIII

Topics

• Clinical Laboratory Techniques
• Dimerization
• Drug Combinations
• Drug Monitoring (methods)
• Factor VIII (administration & dosage, pharmacokinetics)
• Female
• Hemorrhage (drug therapy, etiology)
• Humans
• Male
• Perioperative Care (methods)
• Sterilization
• Treatment Outcome
• von Willebrand Diseases (complications, diagnosis, drug therapy)
• von Willebrand Factor (administration & dosage, pharmacokinetics)