Dalteparin vs Unfractionated Heparin For The Prevention Of Venous Thromboembolism (VTE) In Hospitalized Acutely Ill Medical Patients

NCT00445328 | Terminated Phase 4 Results

• 1 other identifier: A6301080
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to compare the efficacy and safety of dalteparin vs unfractionated heparin for the prevention of VTE (Venous Thromboembolism) in hospitalized acutely ill medical patients.

Conditions

Venous Thromboembolism

Keywords

hospitalised acutely medically ill patients; Venous Thromboembolism, Infection, Inflammatory Bowel Diseases, Heart Failure, Congestive, Sciatica

Outcome Measures

Primary Outcomes (2)

• Confirmed Thromboembolic Events

  Confirmed thromboembolic events = 'present' if any following events are present/abnormal, otherwise = 'absent': Deep vein thrombosis measured by Color Doppler ultrasonography lower limbs; pulmonary embolism by chest xray, ventilation-perfusion scan, computed tomography pulmonary angiography; Sudden Death within 24 hours of venous thromboembolism symptoms.

  Day 21

• Composite of Objectively Verified Thromboembolic Events

  Subjects with objectively verified thromboembolic events: symptomatic proximal and distal deep vein thrombosis \[DVT\], asymptomatic proximal DVT, fatal or symptomatic non-fatal pulmonary embolism \[PE\] or sudden death within 24 hours of onset of venous thromboembolism (VTE) symptoms. Occurrence of any ='Present', otherwise = 'Absent'.

  Day 21

Secondary Outcomes (5)

• All Cause Mortality

  Day 14, Day 21 (End of Study)

• Stroke - Ischemic or Hemorrhagic

  Day 21

• Bleeding - Major or Minor

  Day 21

• Allergic Reactions (Drug-related)

  Day 21

• Thrombocytopenia

  Day 21

Study Arms (2)

B

ACTIVE COMPARATOR

Drug: Unfractionated heparin

A

EXPERIMENTAL

Drug: Dalteparin (Fragmin)

Interventions

Dalteparin (Fragmin) DRUG

Dalteparin 5000 IU once daily subcutaneously for 6-14 days.

A

Unfractionated heparin DRUG

Unfractionated heparin 5000 IU thrice daily subcutaneously for 6-14 days.

B

Eligibility Criteria

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

You may qualify if:

• Aged greater than or equal to 18 years
• Acute medical condition with a projected hospitalization of greater than or equal to 4 days and had less than or equal to 3 days of prior immobilization for more than two thirds of the day
• Acute congestive heart failure Class III-IV per NHYA/ Acute respiratory failure not requiring mechanical ventilation or Both
• Acute infection without septic shock/ Acute episode of inflammatory bowel disease/ Acute rheumatologic disorders/ Acute lumbar pain or sciatica or vertebral compression with at least one risk factor for VTE

You may not qualify if:

• Contraindications to use of anticoagulants
• Active bleeding or abnormal coagulation tests
• Recent (less than 1 month) head injury, hemorrhagic stroke, cerebral tumor or intracranial aneurysm or ischemic stroke within the last month.
• Major surgical or invasive procedure within the last month resulting in ongoing convalescence
• Lumbar or spinal puncture within last 48 hours
• S creatinine levels more than 2
• On inotropic agents

Sponsors & Collaborators

• Pfizer: lead

Study Sites (7)

Pfizer Investigational Site

Hyderabad, Andhra Pradesh, 500 068, India

Location

Pfizer Investigational Site

Ahmedabad, Gujarat, 380 054, India

Location

Pfizer Investigational Site

Thrissur, Kerala, 680 005, India

Location

Pfizer Investigational Site

Indore, Madhya Pradesh, 452001, India

Location

Pfizer Investigational Site

Chennai, Tamil Nadu, 600 006, India

Location

Pfizer Investigational Site

Kolkata, West Bengal, 700 029, India

Location

Pfizer Investigational Site

Kolkata, West Bengal, 700 054, India

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Venous Thromboembolism; Infections; Inflammatory Bowel Diseases; Heart Failure; Sciatica

Interventions

Dalteparin; Heparin

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Heart Diseases; Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Study terminated prematurely due to delay in overall study start-up and inability to meet predefined protocol recruitment milestones; sample size too small to permit meaningful statistical analyses. No statistical analyses for all but 2 endpoints.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 7, 2007
• First Posted: March 8, 2007
• Study Start: June 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: October 15, 2009
• Results First Posted: October 2, 2009

Record last verified: 2009-10

Locations

IN (7)