Heparin-Induced Thrombocytopenia Clinical Trial
Official title:
A 3 Year Retrospective Heparin Induced Thrombocytopenia Registry (HIT) at Brigham and Women's Hospital.
The purpose of the Heparin Induced Thrombocytopenia Registry is to explore the frequency of heparin-induced thrombocytopenia (HIT) at Brigham and Women's Hospital and to assess its mortality rate. Retrospective 3 years, looking forward prospectively.
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 physician's 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.
;
Time Perspective: Retrospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT00759083 -
Bivalirudin PCI Registry in Heparin Induced Thrombocytopenia/Heparin Induced Thrombocytopenia and Thrombosis Syndrome (HIT/HITTS) Patients
|
Phase 4 | |
Completed |
NCT00412464 -
Pilot Dose Finding and Pharmacokinetic Study of Fondaparinux in Children With Thrombosis
|
Phase 1 | |
Terminated |
NCT00673439 -
Fondaparinux for the Treatment of Heparin-Induced Thrombocytopenia (HIT)
|
Phase 2 | |
Active, not recruiting |
NCT00198575 -
A Study on the Prevalence of Heparin-Induced Thrombocytopenia in Cardiovascular Patients
|
N/A | |
Completed |
NCT00283322 -
Heparin Antibodies in Intensive Care Unit Patients (HAICU)
|
N/A | |
Not yet recruiting |
NCT05586854 -
Multicenter Study on Dialysis Modalities for End-stage Chronic Renal Failure Patients With Heparin-induced Thrombocytopenia
|
N/A | |
Not yet recruiting |
NCT03269019 -
Thrombotic Biomarkers to Predict Thrombosis in Heparin-induced Thrombocytopenia
|
N/A | |
Not yet recruiting |
NCT06066762 -
Argatroban Monitoring in Acute Suspected Heparin-induced Thrombocytopenia.
|
||
Terminated |
NCT03809481 -
Open-Label, Randomised, Active Controlled, Multi-Centre Phase 3 Study Safety and Efficacy of Danaparoid vs Argatroban
|
Phase 3 | |
Completed |
NCT05325346 -
A Phase I Study of the Co-administration of VLX-1005 and Argatroban in Healthy Human Subjects
|
Phase 1 | |
Recruiting |
NCT02717039 -
Pharmacogenomics of Heparin-Induced Thrombocytopenia
|
||
Completed |
NCT02526485 -
Immunogenetics of Heparin-Induced Thrombocytopenia: Aim 2
|
||
Completed |
NCT00748839 -
Heparin-Induced Thrombocytopenia: Development and Validation of a Predictive Clinical
|
N/A | |
Recruiting |
NCT05783895 -
Comparison of Pre-test Probability Model for Heparin-induced Thrombocytopenia in Post-operative Cardiac Surgery
|
||
Not yet recruiting |
NCT04782843 -
Evaluation of the Intra-observer Agreement of the HEP Score in Surgical Intensive Care.
|
||
Completed |
NCT00198588 -
Efficacy and Safety Study of Argatroban to Treat Heparin-Induced Thrombocytopenia
|
Phase 3 | |
Recruiting |
NCT04842760 -
PLATELET Function Assay With Flow Imaging on ImageSTREAM Cytometer
|
||
Terminated |
NCT01598168 -
Rivaroxaban for Treatment of Patients With Suspected or Confirmed Heparin-Induced Thrombocytopenia
|
Phase 3 | |
Completed |
NCT01654848 -
Heparin-induced Thrombocytopenia (HIT II) in Liver Transplant Recipients
|
N/A | |
Withdrawn |
NCT00603824 -
Fondaparinux in Patients With Acute Heparin-Induced Thrombocytopenia (HIT)
|
Phase 4 |