Below Knee DVT Study

NCT03805672 | Terminated Phase 4 Results DMC

• 1 other identifier: 9134
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

Hospitalized patients are at risk of developing blood clots in the legs (Deep Vein Thrombosis or DVT), which can lead to death if those clots break off and migrate to the lungs. We know that if there is a blood clot in the large leg veins near the hips and in the thighs, treating these patients with high-doses of blood thinners reduces the risk of these deaths. It is unclear if treating blood clots in the calf with high doses of blood thinners is better than using low doses. In this study, after being diagnosed with a blood clot in the calf, patients will be treated with either low dose or high dose enoxaparin (Lovenox), a blood thinner. We will then see if low dose blood thinner has similar results as high dose blood thinner.

Conditions

Deep Vein Thrombosis (DVT); Blood Clots

Keywords

Lovenox; enoxaparin; DVT

Outcome Measures

Primary Outcomes (1)

• Deep Vein Thrombosis Resolution

  Evaluation of DVT resolution

  6 weeks

Study Arms (2)

Low Dose Enoxaparin

ACTIVE COMPARATOR

Subjects are randomized to receive or begin prophylactic dosing (30 mg BID) of enoxaparin for 6 weeks or until DVT resolution.

Drug: Low Dose Enoxaparin

High Dose Enoxaparin

ACTIVE COMPARATOR

Subjects are randomized to begin therapeutic dosing (1 mg/kg body weight BID) of enoxaparin for 6 weeks or until DVT resolution.

Drug: High Dose Enoxaparin

Interventions

Low Dose Enoxaparin DRUG

Also known as: Lovenox

Low Dose Enoxaparin

High Dose Enoxaparin DRUG

Also known as: Lovenox

High Dose Enoxaparin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over the age of 18 admitted to a trauma or general surgery service will be eligible
• Patients diagnosed with an isolated distal DVT
• Able to obtain informed consent

You may not qualify if:

• Patients with a previous diagnosis of hypercoagulability
• Patients on chronic anticoagulation
• Patients with a history of heparin induced thrombocytopenia
• Patients have preexisting contraindications to anticoagulation
• Patients in renal failure requiring adjusted enoxaparin dosing
• Pregnant patients

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97206, United States

Location

MeSH Terms

Conditions

Venous Thrombosis; Thrombosis

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Samantha Underwood
• Organization: Oregon Health & Science University

underwos@ohsu.edu

503-494-8481

Study Officials

• Martin Schreiber, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Chief of Trauma

Study Record Dates

• First Submitted: January 14, 2015
• First Posted: January 16, 2019
• Study Start: September 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: March 13, 2019
• Results First Posted: March 13, 2019

Record last verified: 2019-02

Locations

US (1)