Heparin or Enoxaparin in Patients With Cancer

Completed

• Conditions: Lymphoma; Thromboembolism; Unspecified Adult Solid Tumor, Protocol Specific
• Interventions: Drug: heparin; Drug: enoxaparin

• Registration Number: NCT00004875
• Lead Sponsor: Northwestern University

Brief Summary

RATIONALE: Heparin or enoxaparin may be effective in preventing the formation of blood clots in patients with cancer who are undergoing surgery to remove the tumor.

PURPOSE: Randomized clinical trial to compare the effectiveness of heparin with that of enoxaparin in patients who have cancer.

Detailed Description

OBJECTIVES: I. Determine the patterns of tissue factor pathway inhibitor (TFPI) release according to tumor type and type of anticoagulation (heparin or enoxaparin) in patients with cancer. II. Determine the incidence of portacath clots and its correlation to TFPI releasability in this patient population. III. Compare these anticoagulation drugs in terms of releasability of TFPI in this patient population.

OUTLINE: This is a randomized study. Patients are stratified according to prior chemotherapy within the past 3 weeks (yes vs no). Patients are randomized to one of two treatment arms. Arm I: Patients receive a single dose of standard heparin subcutaneously (SQ) followed by evaluation of tissue factor pathway inhibitor (TFPI) response at 5 and 10 minutes post injection. Arm II: Patients receive a single dose of enoxaparin SQ followed by evaluation of TFPI response as in arm I. Patients are followed monthly for 3 months.

PROJECTED ACCRUAL: A total of 20-200 patients will be accrued for this study over 6 months.

Study Timeline

• Study Start: 1996-07
• Primary Completion: 1999-03
• Study Completion: 1999-03
• Study First Submitted: 2000-03-07
• Study First Submitted QC: 2004-07-23
• Study First Posted: 2004-07-26
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-18
• Last Update Posted: 2011-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Standard Heparin	heparin	-
Enoxaprin	enoxaparin	-

Trial Locations

Locations (2)

Veterans Affairs Medical Center - Chicago (Lakeside); 🇺🇸 Chicago, Illinois, United States

Evanston Northwestern Health Care; 🇺🇸 Evanston, Illinois, United States