search
Back to results

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

Primary Purpose

Venous Thromboembolism

Status
Terminated
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Dalteparin (Fragmin)
Unfractionated heparin
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Venous Thromboembolism focused on measuring hospitalised acutely medically ill patients; Venous Thromboembolism, Infection, Inflammatory Bowel Diseases, Heart Failure, Congestive, Sciatica

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

B

A

Arm Description

Outcomes

Primary Outcome Measures

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.
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'.

Secondary Outcome Measures

All Cause Mortality
Subjects with death from any cause: end of study.
Stroke - Ischemic or Hemorrhagic
Subjects with stroke (either ischemic or hemorrhagic) based on results of CT (computed tomographic) pulmonary angiography
Bleeding - Major or Minor
Subjects with bleeding. Bleeding classified as major if it is: intraocular, spinal/epidural, intracranial or retroperitoneal; or if hemoglobin decreased by ≥ 2 g/dl(grams/deciliter); or if transfusion of ≥ 2 Units of blood or if significant medical or surgical intervention was required; or if it results in death. All other bleeding is classified as minor.
Allergic Reactions (Drug-related)
Subjects with drug-related allergic reactions
Thrombocytopenia
Subjects with thrombocytopenia (low platelets).

Full Information

First Posted
March 7, 2007
Last Updated
October 5, 2009
Sponsor
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT00445328
Brief Title
Dalteparin vs Unfractionated Heparin For The Prevention Of Venous Thromboembolism (VTE) In Hospitalized Acutely Ill Medical Patients
Official Title
Prospective Randomized Phase IV Open Label Comparative Study Of Dalteparin vs Unfractionated Heparin For The Prevention Of Venous Thromboembolism (VTE) In Hospitalized Acutely Ill Medical Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Terminated
Why Stopped
See Detailed Description
Study Start Date
June 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The study was prematurely discontinued due to delay in overall study start-up and inability to meet pre-defined protocol recruitment milestones on June 30th, 2008. There were no safety concerns regarding the study in the decision to terminate the trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism
Keywords
hospitalised acutely medically ill patients; Venous Thromboembolism, Infection, Inflammatory Bowel Diseases, Heart Failure, Congestive, Sciatica

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
B
Arm Type
Active Comparator
Arm Title
A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Dalteparin (Fragmin)
Intervention Description
Dalteparin 5000 IU once daily subcutaneously for 6-14 days.
Intervention Type
Drug
Intervention Name(s)
Unfractionated heparin
Intervention Description
Unfractionated heparin 5000 IU thrice daily subcutaneously for 6-14 days.
Primary Outcome Measure Information:
Title
Confirmed Thromboembolic Events
Description
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.
Time Frame
Day 21
Title
Composite of Objectively Verified Thromboembolic Events
Description
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'.
Time Frame
Day 21
Secondary Outcome Measure Information:
Title
All Cause Mortality
Description
Subjects with death from any cause: end of study.
Time Frame
Day 14, Day 21 (End of Study)
Title
Stroke - Ischemic or Hemorrhagic
Description
Subjects with stroke (either ischemic or hemorrhagic) based on results of CT (computed tomographic) pulmonary angiography
Time Frame
Day 21
Title
Bleeding - Major or Minor
Description
Subjects with bleeding. Bleeding classified as major if it is: intraocular, spinal/epidural, intracranial or retroperitoneal; or if hemoglobin decreased by ≥ 2 g/dl(grams/deciliter); or if transfusion of ≥ 2 Units of blood or if significant medical or surgical intervention was required; or if it results in death. All other bleeding is classified as minor.
Time Frame
Day 21
Title
Allergic Reactions (Drug-related)
Description
Subjects with drug-related allergic reactions
Time Frame
Day 21
Title
Thrombocytopenia
Description
Subjects with thrombocytopenia (low platelets).
Time Frame
Day 21

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500 068
Country
India
Facility Name
Pfizer Investigational Site
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380 054
Country
India
Facility Name
Pfizer Investigational Site
City
Trichur
State/Province
Kerala
ZIP/Postal Code
680 005
Country
India
Facility Name
Pfizer Investigational Site
City
Indore
State/Province
Madhya Pradesh
ZIP/Postal Code
452001
Country
India
Facility Name
Pfizer Investigational Site
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600 006
Country
India
Facility Name
Pfizer Investigational Site
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700 029
Country
India
Facility Name
Pfizer Investigational Site
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700 054
Country
India

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6301080&StudyName=Dalteparin%20vs%20Unfractionated%20Heparin%20For%20The%20Prevention%20Of%20Venous%20Thromboembolism%20%28VTE%29%20In%20Hospitalized%20Acutely%20ill%20Medical%20Patients
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

We'll reach out to this number within 24 hrs