A Single and Low Dose of Recombinant Factor VIIa in Patients With Severe Factor XI Deficiency Undergoing Surgery
Information source: Sheba Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hemophilia C
Intervention: recombinant factor VIIa (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Sheba Medical Center Overall contact: Ophira Salomon, MD, Phone: 97235302104, Email: ophiras@sheba.health.gov.il
Summary
Lately the investigators found that patients with severe factor XI deficiency and inhibitors
could undergo major surgery with a single low dose of recombinant factor VIIa and tranexamic
agent. These results encourage us to apply this treatment in clinical trial setting to
patients with severe factor XI deficiency undergoing surgery instead of blood product.
Clinical Details
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Improvement in prophylactic treatment by using single and low dose recombinant FVIIa in patients with severe FXI deficiency
Detailed description:
Eligible patients will be those with severe factor XI deficiency who agree to participate in
the study . The treatment does not apply to patients requiring coronary artery bypass or
other vascular surgery.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- patients with severe factor XI deficiency who will give informed consent to
participate in the study
Exclusion Criteria:
- patients with atherosclerosis disease i. e. unstable angina pectoris or recent stroke
- Patients who required aorto-coronary bypass or any vascular surgery
Locations and Contacts
Ophira Salomon, MD, Phone: 97235302104, Email: ophiras@sheba.health.gov.il
Ophira Salomon, Ramat -Gan, Israel; Not yet recruiting Ophira salomon, MD, Phone: 01197235302104, Email: ophiras@sheba.health.gov.il Uri Seligsohn, MD, Phone: 01197235302104, Email: Uri.Seligson@sheba.health.gov.il Uri Seligsohn, MD, Sub-Investigator Ophira Salomon, MD, Principal Investigator
Sheba Medical Center, Ramat-Gan, Israel
Sheba Medical Center, Tel Hashomer, Ramat-Gan, Israel; Enrolling by invitation
Additional Information
Related publications: Salomon et al presented at ASH 2008 entitled
Starting date: February 2012
Last updated: February 22, 2012
|