NCT01538160

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2012

Completed
13 days until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 23, 2012

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

February 23, 2012

Status Verified

February 1, 2012

Enrollment Period

3.4 years

First QC Date

January 19, 2012

Last Update Submit

February 22, 2012

Conditions

Hemophilia C

Keywords

recombinant factor VIIafactor XI deficiency

Outcome Measures

Primary Outcomes (1)

  • Improvement in prophylactic treatment by using single and low dose recombinant FVIIa in patients with severe FXI deficiency

    End point to be assessed the degree of bleeding following major operation under rFVIIa

    1 week

Interventions

recombinant factor VIIaDRUG

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

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with severe factor XI deficiency who will give informed consent to participate in the study

You may not qualify if:

  • patients with atherosclerosis disease i.e. unstable angina pectoris or recent stroke
  • Patients who required aorto-coronary bypass or any vascular surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Ophira Salomon

Ramat Gan, Israel

Location

Sheba Medical Center

Ramat Gan, Israel

Location

Sheba Medical Center

Tel Hashomer, Ramat-Gan, Israel

Location

Related Publications (1)

  • Salomon et al presented at ASH 2008 entitled

    BACKGROUND

MeSH Terms

Conditions

Factor XI Deficiency

Interventions

recombinant FVIIa

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Ophira Salomon, MD

CONTACT

97235302104ophiras@sheba.health.gov.il

Uri Seligsohn, MD

CONTACT

97235302104Uri.Seligson@sheba.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2012

First Posted

February 23, 2012

Study Start

February 1, 2012

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

February 23, 2012

Record last verified: 2012-02

Locations

IL(3)