CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 67 enrolled
Drug / intervention
Dalteparin sodium injection +1 moredrug
Likely dose
Dalteparin 200 units/kg subcutaneously daily for one month, followed by 150 units/kg subcutaneously daily for two additional months; or 200 units/kg subcutaneously daily for 5 days followed by warfarin (INR 2-3)AI-extracted
Key inclusion· 1
  • ✓Confirmed upper extremity DVT diagnosed by ultrasound imaging or venogram
Key exclusion· 9
  • ✕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

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00245856
NCT00245856Phase 4Completed
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Treatment of Upper Extremity Deep-Vein Thrombosis

University of Oklahoma·interventional·Posted Oct 28, 2005·Updated Feb 21, 2013

In Brief

A Phase 4 clinical trial evaluating Dalteparin sodium injection and Warfarin for Deep-Vein Thrombosis. Completed, enrolled 67 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDeep-Vein Thrombosis
CountriesUnited States
CollaboratorsPfizer

Timeline

Phase 4CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 28, 2005
Enrollment StartSep 1, 2002
Primary CompletionMar 1, 2009
Study CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 20.7 years ago

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.

Warfarindrug

Titrated to INR 2-3 through study month 3