NCT01878916

Brief Summary

Hyperhomocysteinemia is a risk for thrombosis. Thrombosis is more frequent in myeloproliferative neoplasms (MPNs) than the normal population. In this study, we investigated the thrombosis incidence, the effects of plasma homocysteine levels on thrombosis, and the correlations between folate, cobalamin, pyridoxine and homocysteine levels in MPNs, and to compare these results with the healthy controls.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jan 2003

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
9 years until next milestone

First Submitted

Initial submission to the registry

May 29, 2013

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 17, 2013

Completed
Last Updated

June 17, 2013

Status Verified

June 1, 2013

Enrollment Period

1.4 years

First QC Date

May 29, 2013

Last Update Submit

June 14, 2013

Conditions

Thrombosis

Keywords

the incidence of thrombosis,the effect of Hcy on thrombosis formation,the relation between Hcy and plasma vitamin levels,to compare these results with the control group

Outcome Measures

Primary Outcomes (1)

  • Thrombosis

    at least 1 year

Secondary Outcomes (1)

  • High Hcy level

    1 year

Other Outcomes (1)

  • Death

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Between January and June 2003, thirty-one new or formerly diagnosed MPN patients who consecutively visitted our clinic, as well as 40 age and sex matched healthy controls were enrolled in this study.

You may qualify if:

  • Adult MPN patients and healthy controls who gave a written consent were included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University Cerrahpasa Medical Faculty

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Ahmet Emre Eskazan, MD

    Istanbul University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 29, 2013

First Posted

June 17, 2013

Study Start

January 1, 2003

Primary Completion

June 1, 2004

Study Completion

June 1, 2004

Last Updated

June 17, 2013

Record last verified: 2013-06

Locations

TU(1)