Retrospective Registry of Patients With Acute Heparin-induced Thrombocytopenia Type II

Study Overview
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Brief Summary
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The purpose of this retrospective registry is to collect data about patients with acute HIT II (Heparin-induced Thrombocytopenia type II) which were treated with Lepirudin, Danaparoid, Argatroban or Fondaparinux. It is a main objective of this registry to mirror the daily routine in this indication in Germany.

Official Title
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Systematische Dokumentation Von Patienten Mit Akutem HIT-Verdacht

Conditions
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Acute HIT II (Heparin-induced Thrombocytopenia Type II)

Intervention / Treatment
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* Drug: lepirudin
* Drug: danaparoid
* Drug: argatroban
* Drug: fondaparinux


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute HIT II (Heparin-induced Thrombocytopenia type II), 4T-Score Treatment of HIT with Lepirudin, Danaparoid, Argatroban or Fondaparinux Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| lepirudin<br>lepirudin treated subjects | Drug: lepirudin<br>* lepirudin<br>|
| danaparoid<br>danaparoid treated subjects | Drug: danaparoid<br>* danaparoid<br>|
| argatroban<br>argatroban treated subjects | Drug: argatroban<br>* argatroban<br>|
| fondaparinux<br>fondaparinux treated subjects | Drug: fondaparinux<br>* fondaparinux<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | Thrombosis is a clotting in a blood vessel. Pulmonary embolism is a clot, usually from the deep veins of the legs, carried away with the venous bloodstream into the lungs, where it may block pulmonary vessels. Participants' medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs). | 19 January 2005 to 25 October 2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Diagnosed With Bleeding After the Occurrence of HIT II | Participants' medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs). Bleeding was documented in the participant files. | 19 January 2005 to 25 October 2009 | 
| Number of Participants With Fatal Complications After the Occurrence of HIT II | Participants' medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs). A fatal complication is defined as a complication resulting in death. | 19 January 2005 to 25 October 2009 | 
| Number of Participants Who Underwent Amputation After the Occurrence of HIT II | Participants' medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs). | 19 January 2005 to 25 October 2009 | 
| Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II | Participants' medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs). Thrombocytopenia after HIT-II was documented in the participant files. | 19 January 2005 to 25 October 2009 | 
| Number of Participants Who Experienced Skin Changes (Erythema and Necrosis) After the Occurrence of HIT II | Participants' medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs). Erythema is a redness of the skin caused by hyperemia. Necrosis is the premature death of cells or tissues. | 19 January 2005 to 25 October 2009 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Retrospective evaluation of patients with acute Heparin-induced Thrombocytopenia type II treated with Fondaparinux