A Study of Dalteparin Prophylaxis in High-Risk Ambulatory Cancer Patients

Study summary

Some cancer patients starting a new chemotherapy regimen are likely to develop blood clots, also known as venous thromboembolism (VTE). Blood clots can cause symptoms and can occasionally be life-threatening. The purpose of this study is to determine if a daily injection of a blood-thinner, dalteparin, for 12 weeks can safely and effectively reduce the frequency of blood clots. Dalteparin is currently approved for prevention of blood clots following surgery and in hospitalized patients but not specifically for cancer outpatients.

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Key things to know

Main goalPrevention

This describes the study’s primary purpose.

What is being studieddalteparin injection

The study team can explain what participation involves.

Who it may be forVenous Thromboembolism · Pulmonary Embolism

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Nov 24, 2015 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?7 U.S. locations

Locations may change over time.

Who runs it?University of Rochester

Study sponsor

Study overview

What this study is about

Purpose: Prevention
Study type: Interventional
Phase: Phase 3
Sponsor: University of Rochester
Interventions being studied: Drug: dalteparin injection

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach

Chemotherapy→Surgery→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

A histologic diagnosis of malignancy;
At planned initiation of a new systemic chemotherapy regimen (including patients starting on first chemotherapy or patients previously treated but starting on a new regimen);
A risk score for VTE ≥3 \[assign score of 2 for very high risk sites of cancer (stomach, pancreas), score of 1 for high risk site (lung, lymphoma, gynecologic, bladder, testicular) and score of 0 for all other sites\], hemoglobin \<10 g/dL or planned use of erythropoiesis stimulating agents, platelet count ≥350,000/mm3, total leukocyte count \> 11,000/mm3 or body mass index ≥ 35 kg/m2\]. Any counts meeting criteria drawn within 2 weeks prior to enrollment are considered acceptable.
Age 18 years or older
Provide written, informed consent.

Reasons someone may not be able to joinExclusion criteria

Active bleeding or at high risk of serious bleeding complication in the opinion of the investigator
Diagnosis of primary brain tumor multiple myeloma, leukemia, or myelodysplastic syndrome
Planned stem cell transplant
Life expectancy \< 6 months
Known allergy to heparin or LMWH
Patient or caregiver incapable of daily self-injection
Acute or chronic renal insufficiency with creatinine clearance \< 30 mL/min
History of heparin-induced thrombocytopenia
Allergy to contrast agents
Pregnancy
Need for anticoagulant therapy
Platelet count \< 75,000/mm3

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

University of California, DavisSacramento, California
Roswell Park Cancer InstituteBuffalo, New York
Rochester General HospitalRochester, New York
University of Rochester Medical CenterRochester, New York
Duke University School of MedicineDurham, North Carolina
Cleveland ClinicCleveland, Ohio
Ottawa Hospital Research Institute (OHRI)Ottawa, Ontario

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 24, 2015. Always confirm current availability with the study team.

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