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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

Page last updated: August 23, 2015

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