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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Eisai Inc.
Information provided by (Responsible Party):
Charles Francis, University of Rochester
ClinicalTrials.gov Identifier:
NCT00876915
First received: March 31, 2009
Last updated: April 4, 2014
Last verified: April 2014

March 31, 2009
April 4, 2014
July 2009
July 2014   (final data collection date for primary outcome measure)
To conduct a prospective, randomized clinical trial comparing the safety and efficacy of prophylaxis with dalteparin to no treatment in reducing VTE in high-risk ambulatory cancer patients initiating chemotherapy. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00876915 on ClinicalTrials.gov Archive Site
To establish the value of tissue factor (TF) as a predictive marker for VTE in ambulatory cancer patients receiving chemotherapy. [ Time Frame: baseline evaluation of tissue factor and then monthly for 4 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Dalteparin Prophylaxis in High-Risk Ambulatory Cancer Patients
A Prospective Randomized Multicenter Study of Dalteparin Prophylaxis in High-Risk Ambulatory Cancer Patients

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Venous Thromboembolism
  • Pulmonary Embolism
Drug: dalteparin injection
Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl).
Other Name: Fragmin
  • Experimental: dalteparin injection
    Patients will be assigned at random to receive prophylactic dalteparin injections
    Intervention: Drug: dalteparin injection
  • No Intervention: No therapy
    No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
229
Not Provided
July 2014   (final data collection date for primary outcome measure)

Inclusion 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.

Exclusion 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00876915
25387, 1 R01 HL95109-01
Yes
Charles Francis, University of Rochester
University of Rochester
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Eisai Inc.
Principal Investigator: Charles W. Francis, MD Univeristy of Rochester Medical Center
University of Rochester
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP