NCT00245856

Brief Summary

The purpose of this study is to document the long-term outcome or prognosis of patients diagnosed with upper extremity deep-vein thrombosis who are treated with Fragmin (dalteparin sodium injection) for three months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2002

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

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

September 1, 2002

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

October 26, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 28, 2005

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

February 4, 2013

Completed
Last Updated

February 21, 2013

Status Verified

February 1, 2013

Enrollment Period

6.5 years

First QC Date

October 26, 2005

Results QC Date

February 1, 2013

Last Update Submit

February 15, 2013

Conditions

Deep-Vein Thrombosis

Keywords

Upper Extremity Deep-Vein ThrombosisDVTFragminDeep-Vein ThrombosisThrombosis

Outcome Measures

Primary Outcomes (2)

  • Percentage of Participants That Died at 3 Months

    3 months

  • New Venous Thromboembolism at 3 Months

    New DVT or PE at 3 months confirmed by diagnostic testing

    3 months

Secondary Outcomes (1)

  • Bleeding Events

    3 months

Study Arms (1)

Treatment of Upper Extremity DVT

EXPERIMENTAL

Participants received dalterparin followed by warfarin or received dalterparin monotherapy for the treatment of upper extremity DVT

Drug: Dalteparin sodium injectionDrug: Warfarin

Interventions

Dalteparin sodium injectionDRUG

200units/kg subcutaneous daily for one month, followed by 150units/kg subcutaneous daily for two additional months or 200 units/kg subcutaneously daily for 5 days followed by warfarin.

Also known as: Fragmin
Treatment of Upper Extremity DVT
WarfarinDRUG

Titrated to INR 2-3 through study month 3

Treatment of Upper Extremity DVT

Eligibility Criteria

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

You may qualify if:

  • Patients with confirmed upper extremity DVT diagnosed by ultrasound imaging or venogram

You may not qualify if:

  • Active, clinically significant bleeding
  • Known hypersensitivity to heparin or low-molecular weight heparin
  • Currently pregnant or less than 1 week post-partum
  • Acquired bleeding diathesis
  • Known inherited bleeding disorder
  • Renal failure
  • Extremes of weight
  • Poor performance status
  • Unable to return for repeat diagnostic testing or follow-up visits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Veterans Affairs Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

University of Oklahoma Health Science Center

Oklahoma City, Oklahoma, 73117, United States

Location

MeSH Terms

Conditions

Venous ThrombosisUpper Extremity Deep Vein ThrombosisThrombosis

Interventions

DalteparinWarfarin

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Suman Rathbun MD
Organization
University of Oklahoma Health Sciences Center
suman-rathbun@ouhsc.edu
4052714742

Study Officials

  • Suman W. Rathbun, M.D.

    University of Oklahoma Health Science Center, Dept of Medicine/CardioVascular section

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

October 26, 2005

First Posted

October 28, 2005

Study Start

September 1, 2002

Primary Completion

March 1, 2009

Study Completion

December 1, 2011

Last Updated

February 21, 2013

Results First Posted

February 4, 2013

Record last verified: 2013-02

Locations

US(2)