A Single and Low Dose of Recombinant Factor VIIa in Patients With Severe Factor XI Deficiency Undergoing Surgery

NCT ID: NCT01538160

Last Updated: 2012-02-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2015-07-31

Brief 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.

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.

Conditions

Hemophilia C

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

recombinant factor VIIa

single dose of 20ug/kg of recombinant factor VIIa along with tranexamic acid of 4 gram a day for 7 days following surgery

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ophira Salomon

Ramat Gan, , Israel

Sheba Medical Center

Ramat Gan, , Israel

Sheba Medical Center

Tel Hashomer, Ramat-Gan, , Israel

Countries

Israel

Central Contacts

Ophira Salomon, MD

Role: CONTACT

ophiras@sheba.health.gov.il

97235302104

Uri Seligsohn, MD

Role: CONTACT

Uri.Seligson@sheba.health.gov.il

97235302104

Facility Contacts

Ophira salomon, MD

Role: primary

ophiras@sheba.health.gov.il

01197235302104

Uri Seligsohn, MD

Role: backup

Uri.Seligson@sheba.health.gov.il

01197235302104

References

Salomon et al presented at ASH 2008 entitled

Reference Type: BACKGROUND

Other Identifiers

SHEBA-11-8657-OS-CTIL

Identifier Type: -

Identifier Source: org_study_id