NCT01109667

Brief Summary

The aim of this study is to assess the effect of Innovin® reagent on laboratory results when compared with the Thromborel® S.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Shorter than P25 for all trials

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, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 23, 2010

Completed
Last Updated

April 23, 2010

Status Verified

January 1, 2010

Enrollment Period

2 months

First QC Date

April 22, 2010

Last Update Submit

April 22, 2010

Conditions

Effect of Different Reagents.Oral Anticoagulant Therapy

Keywords

Thromboplastin, Prothrombin, Diagnostic Reagent Kits, International Normalized Ratio, Laboratory Tests.

Study Arms (2)

oral anticoagulant

Patients receiving and not receiving oral anticoagulant therapy.

INR Level

Group I: Patients not receiving OAT, Group II: Patients under OAT and INR values in good therapeutic range and Group III: Patients under OAT and INR values over the therapeutic range.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients receiving and not receiving oral anticoagulant therapy

You may qualify if:

  • Routine control patients receiving and not receiving oral anticoagulant therapy

You may not qualify if:

  • Hemolytic and/or lipemic samples were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turkiye Yuksek Ihtisas Hospital

Ankara, 06100, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 22, 2010

First Posted

April 23, 2010

Study Start

January 1, 2010

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

April 23, 2010

Record last verified: 2010-01

Locations

TU(1)