---
title: Treatment of Upper Extremity Deep-Vein Thrombosis
nct_id: NCT00245856
overall_status: COMPLETED
phase: PHASE4
sponsor: University of Oklahoma
study_type: INTERVENTIONAL
primary_condition: Deep-Vein Thrombosis
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00245856.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00245856"
ct_last_update_post_date: 2013-02-21
last_seen_at: "2026-05-12T06:22:54.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Treatment of Upper Extremity Deep-Vein Thrombosis

**NCT ID:** [NCT00245856](https://clinicaltrials.gov/study/NCT00245856)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 67
- **Lead Sponsor:** University of Oklahoma
- **Collaborators:** Pfizer
- **Conditions:** Deep-Vein Thrombosis
- **Start Date:** 2002-09
- **Completion Date:** 2011-12
- **CT.gov Last Update:** 2013-02-21

## 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.

## Detailed Description

Upper extremity deep-vein thrombosis (DVT) is an increasingly common clinical problem and has been found to cause important pulmonary embolism in up to 36% of cases including fatal embolism. The major risk factor for development of DVT is presence of a central venous catheter in which up to 30% of patients may develop venous thrombosis. Peripherally inserted central catheters or (PICC) lines have been more frequently used in order to avoid the morbidity of central venous catheter insertion. There is little data on the incidence of DVT with these catheters, or effective treatment regimen.

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. About 100 patients will be enrolled in this study at the University of Oklahoma.

All patients with upper extremity DVT will be screened. Each will have a complete baseline and risk factor assessment.

All patients will receive active study drug for a period of 3 months with reassessment of upper extremity DVT by ultrasound.

All patients will participate for a period of 12 months with follow up visits at 5-7 day, and 1, 3, 6, 12 months.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Treatment of Upper Extremity DVT** (EXPERIMENTAL) — Participants received dalterparin followed by warfarin or received dalterparin monotherapy for the treatment of upper extremity DVT

## Interventions

- **Dalteparin sodium injection** (DRUG) — 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.
- **Warfarin** (DRUG) — Titrated to INR 2-3 through study month 3

## Primary Outcomes

- **Percentage of Participants That Died at 3 Months** _(time frame: 3 months)_
- **New Venous Thromboembolism at 3 Months** _(time frame: 3 months)_ — New DVT or PE at 3 months confirmed by diagnostic testing

## Secondary Outcomes

- **Bleeding Events** _(time frame: 3 months)_

## Locations (2)

- Department of Veterans Affairs Medical Center, Oklahoma City, Oklahoma, United States
- University of Oklahoma Health Science Center, Oklahoma City, Oklahoma, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.department of veterans affairs medical center|oklahoma city|oklahoma|united states` — added _(2026-05-12)_
- `locations.university of oklahoma health science center|oklahoma city|oklahoma|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00245856.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00245856*  
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