Phase 4 N=28 Treatment

Treatment of Upper Extremity Deep-Vein Thrombosis

Deep-Vein Thrombosis

Bottom Line

View on ClinicalTrials.gov: NCT00245856 ↗

Enrolled (actual)

Serious AEs

3.0%

Results posted

Feb 2013

Primary outcome: Primary: Percentage of Participants That Died at 3 Months — 8; 0 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Dalteparin sodium injection (Drug); Warfarin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Oklahoma
Primary completion: Mar 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants That Died at 3 Months	8; 0	—
PRIMARY New Venous Thromboembolism at 3 Months	—	—
SECONDARY Bleeding Events	1	—

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00245856). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.