NCT00736008

Brief Summary

The study will assess the clinical and laboratory data of about 100 pediatric patients diagnosed and treated at the Pediatric Hematology Unit during the years 1980 until 2007 because of thrombotic events. The results, the treatment given, and the outcome of the patients will be summarized.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2008

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 15, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

August 26, 2011

Status Verified

August 1, 2011

Enrollment Period

1.3 years

First QC Date

August 14, 2008

Last Update Submit

August 25, 2011

Conditions

Keywords

Factor V LeidenProthrombin MutationHypercoagulabilityPediatrics

Study Arms (1)

A

Patients with thromboembolic events

Other: Observational

Interventions

Data summary only

A

Eligibility Criteria

AgeUp to 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The population cohort will include about 100 patients diagnosed with thrombotic events at the Pediatric Hematology Unit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Hematology Unit - Ha'Emek Medical Center

Afula, Afula, 18101, Israel

Location

MeSH Terms

Conditions

ThrombosisThrombophilia

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Carina Levin, MD

    Pediatric Hematology Unit - Ha'Emek Medical Center - Afula - 18101 - Israel

    PRINCIPAL INVESTIGATOR
  • Ayala Mari, Student

    Pediatric Dpt B - Ha'Emek Medical Center - Afula - Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Pediatric Hematology Unit and Pediatric Dpt B

Study Record Dates

First Submitted

August 14, 2008

First Posted

August 15, 2008

Study Start

May 1, 2008

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

August 26, 2011

Record last verified: 2011-08

Locations