In vivo changes in haemostasis after intravenous administration of plasma-derived factor VII and recombinant factor VII(a)

Completed

• Conditions: Factor VII deficiency; Haematological Disorders; Other specified coagulation defects

• Registration Number: ISRCTN04929580
• Lead Sponsor: Radboud University Nijmegen Medical Center (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-12
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Factor VII clotting activity of less than 5%
2. Age 18 years or older
3. Wash-out period of pdFVII or rFVII(a) of at least 3 days
4. Male or female
5. The intention to participate in a cross-over design (treated-twice)

Exclusion Criteria

1. Age < 18 years
2. Known allergy to plasma proteins
3. Bleeding episode resulting in a drop in haemoglobin (Hb) levels of >1 mmol/l (64.5 g/l), trauma or surgery in the last 6 weeks
4. Fever (> 38 degrees centigrade)
5. Clinical indication of liver cirrhosis (echographic indication, enlarged spleen, enlarged liver, decreased platelet count)
6. Hepatitis C recently treated with interferon (wash-out 6 months)
7. Human immunodeficiency virus (HIV) positive
8. Pregnancy
9. Medication:
9.1. Non-steroid anti-inflammatory drugs (NSAIDs)
9.2. Clopidogrel
9.3. Antimicrobial medication
9.4. Thyroid inhibitors
9.5. Serotonin-specific reuptake inhibitor (SSRI?s)
9.6. Hb levels < 7.5 mmol/l for women, < 8.4 mmol/l for men

Study & Design

• Study Type: Interventional
• Study Design: Not specified