Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00456326
Status:
COMPLETED
Last Update Posted:
2008-02-18
First Post:
2007-04-02
Brief Title:
Heparin-Induced Thrombocytopenia Registry
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
A 3 Year Retrospective Heparin Induced Thrombocytopenia Registry HIT at Brigham and Womens Hospital
Status:
COMPLETED
Status Verified Date:
2008-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HIT
Brief Summary:
The purpose of the Heparin Induced Thrombocytopenia Registry is to explore the frequency of heparin-induced thrombocytopenia HIT at Brigham and Womens Hospital and to assess its mortality rate Retrospective 3 years looking forward prospectively
Detailed Description:
Heparin-induced thrombocytopenia HIT is an immune-mediated adverse drug reaction with potentially fatal complications of venous and arterial thrombosis
HIT with thrombosis causes prolonged hospital length of stay and is associated with catastrophic outcomes such as extremity amputation as well as death The fear of HIT has led to some proposals to minimize hospital use of unfractionated heparin UFH and low molecular weight heparin LMWH and to substitute other anticoagulants that have not been reported to cause HIT Therefore the frequency of confirmed HIT and the frequency of determining whether UFH or LMWH is the causative agent urgently require further investigation
At BWH we have placed patient safety at a premium We have a Patient Safety Committee and a Patient Safety Officer HIT has been identified as one of the primary problems requiring urgent policy decisions Consequently we have formed a multi-disciplinary team of physicians pharmacists nurses and physicians assistants to improve safe medication practices for patients receiving anticoagulation
Our primary objectives are to establish an HIT registry which will provide information on
1 Incidence of HIT associated with UFH and LMWH
2 Outcomes of patients with HIT
3 Adverse events associated with alternative anticoagulants used to treat HIT
We will obtain data with respect to Drug Dose Route of administration Duration of therapy Platelet count Platelet nadir Co-morbidities Coronary Artery Disease Diabetes Mellitus Myocardial Infarction Hypertension Pulmonary Disease Chronic Renal Failure Malignancy Liver Disease Surgery Sepsis Baseline characteristics Age Sex Weight Pregnancy status Serum Creatinine AST ALT Hematocrit Hemoglobin Venous and Arterial Thrombotic events DVT PE CVC 30-day mortality rate alternative anticoagulant therapy and duration of therapy
Time and Method of Data Collection
Chart Review for the duration of hospitalization Hemorrhagic event Thrombotic events and 30-day Mortality Rate
HIT with thrombosis causes prolonged hospital length of stay and is associated with catastrophic outcomes such as extremity amputation as well as death The fear of HIT has led to some proposals to minimize hospital use of unfractionated heparin UFH and low molecular weight heparin LMWH and to substitute other anticoagulants that have not been reported to cause HIT Therefore the frequency of confirmed HIT and the frequency of determining whether UFH or LMWH is the causative agent urgently require further investigation
At BWH we have placed patient safety at a premium We have a Patient Safety Committee and a Patient Safety Officer HIT has been identified as one of the primary problems requiring urgent policy decisions Consequently we have formed a multi-disciplinary team of physicians pharmacists nurses and physicians assistants to improve safe medication practices for patients receiving anticoagulation
Our primary objectives are to establish an HIT registry which will provide information on
1 Incidence of HIT associated with UFH and LMWH
2 Outcomes of patients with HIT
3 Adverse events associated with alternative anticoagulants used to treat HIT
We will obtain data with respect to Drug Dose Route of administration Duration of therapy Platelet count Platelet nadir Co-morbidities Coronary Artery Disease Diabetes Mellitus Myocardial Infarction Hypertension Pulmonary Disease Chronic Renal Failure Malignancy Liver Disease Surgery Sepsis Baseline characteristics Age Sex Weight Pregnancy status Serum Creatinine AST ALT Hematocrit Hemoglobin Venous and Arterial Thrombotic events DVT PE CVC 30-day mortality rate alternative anticoagulant therapy and duration of therapy
Time and Method of Data Collection
Chart Review for the duration of hospitalization Hemorrhagic event Thrombotic events and 30-day Mortality Rate
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None