Venous Thromboembolism Clinical Trial
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.
| Verified date | October 2009 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | India: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 84 |
| Est. completion date | July 2008 |
| Est. primary completion date | July 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| India | Pfizer Investigational Site | Ahmedabad | Gujarat |
| India | Pfizer Investigational Site | Chennai | Tamil Nadu |
| India | Pfizer Investigational Site | Hyderabad | Andhra Pradesh |
| India | Pfizer Investigational Site | Indore | Madhya Pradesh |
| India | Pfizer Investigational Site | Kolkata | West Bengal |
| India | Pfizer Investigational Site | Kolkata | West Bengal |
| India | Pfizer Investigational Site | Trichur | Kerala |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
India,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Confirmed Thromboembolic Events | Day 21 | Yes | |
| Primary | Composite of Objectively Verified Thromboembolic Events | Day 21 | Yes | |
| Secondary | All Cause Mortality | Day 14, Day 21 (End of Study) | Yes | |
| Secondary | Stroke - Ischemic or Hemorrhagic | Day 21 | Yes | |
| Secondary | Bleeding - Major or Minor | Day 21 | Yes | |
| Secondary | Allergic Reactions (Drug-related) | Day 21 | Yes | |
| Secondary | Thrombocytopenia | Day 21 | Yes |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05347550 -
Examining the Benefit of Graduated Compression Stockings in the Prevention of vEnous Thromboembolism in Low-risk Surgical Patients
|
N/A | |
| Enrolling by invitation |
NCT05794165 -
Antithrombin to Improve Thromboprophylaxis and Reduce the Incidence of Trauma-Related Venous Thromboembolism
|
Phase 2 | |
| Completed |
NCT02379806 -
The SYMPTOMS - SYstematic Elderly Medical Patients Thromboprophylaxis: Efficacy on Symptomatic OutcoMeS - Study
|
Phase 3 | |
| Recruiting |
NCT03691753 -
Safety and Efficacy Study of Fitaya Vena Cava Filter
|
N/A | |
| Completed |
NCT02197416 -
Safety of Dabigatran Etexilate in Blood Clot Prevention in Children
|
Phase 3 | |
| Recruiting |
NCT05378035 -
DOAC in Chinese Patients With Atrial Fibrillation
|
||
| Recruiting |
NCT05171075 -
A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/Genitourinary Cancer and Associated VTE
|
Phase 3 | |
| Completed |
NCT01895777 -
Open Label Study Comparing Efficacy and Safety of Dabigatran Etexilate to Standard of Care in Paediatric Patients With Venous Thromboembolism (VTE)
|
Phase 3 | |
| Completed |
NCT05897697 -
Assessing Women's Preferences for Postpartum Thromboprophylaxis: the Prefer-Postpartum Study
|
||
| Completed |
NCT04736420 -
Replication of the EINSTEIN-DVT Anticoagulant Trial in Healthcare Claims Data
|
||
| Completed |
NCT04736719 -
Replication of the AMPLIFY Anticoagulant Trial in Healthcare Claims Data
|
||
| Completed |
NCT04735523 -
Replication of the RECOVER-II Anticoagulant Trial in Healthcare Claims Data
|
||
| Completed |
NCT02829957 -
RAMBLE - Rivaroxaban vs. Apixaban for Heavy Menstrual Bleeding
|
Phase 2/Phase 3 | |
| Completed |
NCT02746185 -
Cancer Associated Thrombosis, a Pilot Treatment Study Using Rivaroxaban
|
Phase 3 | |
| Completed |
NCT02912234 -
Effect of Clarithromycin on the Pharmacokinetics of Apixaban in Healthy Participants
|
Phase 1 | |
| Completed |
NCT02334007 -
Extended Low-Molecular Weight Heparin VTE Prophylaxis in Thoracic Surgery
|
Phase 1/Phase 2 | |
| Completed |
NCT02223260 -
Tolerability , PK/PD and Safety of Dabigatran Etexilate Oral Liquid Formulation in Children < 1 Year of Age
|
Phase 2 | |
| Completed |
NCT02661568 -
Description of Patients With Acute Venous Thromboembolism in the UK's Clinical Practice Research Datalink Linked With Hospital Episode Statistics Dataset (CPRD-HES)
|
N/A | |
| Completed |
NCT01976988 -
Prospective Study on Preoperative Versus Postoperative Venous Thromboprophylaxis in Patients Undergoing Major Colorectal Surgery
|
Phase 3 | |
| Completed |
NCT01972243 -
Risk of Recurrent Venous Thrombosis: A Validation Study of the Vienna Prediction Model
|