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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01538160
Recruitment Status : Unknown
Verified February 2012 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : February 23, 2012
Last Update Posted : February 23, 2012
Information provided by (Responsible Party):
Sheba Medical Center

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.

Condition or disease Intervention/treatment Phase
Hemophilia C Drug: recombinant factor VIIa Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2012
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2015

Intervention Details:
  • Drug: 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

Primary Outcome Measures :
  1. Improvement in prophylactic treatment by using single and low dose recombinant FVIIa in patients with severe FXI deficiency [ Time Frame: 1 week ]
    End point to be assessed the degree of bleeding following major operation under rFVIIa

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01538160

Contact: Ophira Salomon, MD 97235302104
Contact: Uri Seligsohn, MD 97235302104

Ophira Salomon Not yet recruiting
Ramat -Gan, Israel
Contact: Ophira salomon, MD    01197235302104   
Contact: Uri Seligsohn, MD    01197235302104   
Sub-Investigator: Uri Seligsohn, MD         
Principal Investigator: Ophira Salomon, MD         
Sheba Medical Center
Ramat-Gan, Israel
Sheba Medical Center Enrolling by invitation
Tel Hashomer, Ramat-Gan, Israel
Sponsors and Collaborators
Sheba Medical Center

Salomon et al presented at ASH 2008 entitled

Responsible Party: Sheba Medical Center Identifier: NCT01538160     History of Changes
Other Study ID Numbers: SHEBA-11-8657-OS-CTIL
First Posted: February 23, 2012    Key Record Dates
Last Update Posted: February 23, 2012
Last Verified: February 2012

Keywords provided by Sheba Medical Center:
recombinant factor VIIa
factor XI deficiency

Additional relevant MeSH terms:
Factor XI Deficiency
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn