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

Completed

• Conditions: Acute HIT II (Heparin-induced Thrombocytopenia Type II)
• Interventions: Drug: fondaparinux; Drug: lepirudin; Drug: danaparoid; Drug: argatroban

• Registration Number: NCT01304238
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Study First Submitted: 2011-01-27
• Study First Submitted QC: 2011-01-27
• Results First Submitted: 2011-01-27
• Results First Submitted QC: 2011-01-27
• Study First Posted: 2011-02-25
• Results First Posted: 2011-02-25
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-06
• Last Update Posted: 2017-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 195

Inclusion Criteria

• Acute HIT II (Heparin-induced Thrombocytopenia type II), 4T-Score
• Treatment of HIT with Lepirudin, Danaparoid, Argatroban or Fondaparinux

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
fondaparinux	fondaparinux	fondaparinux treated subjects
lepirudin	lepirudin	lepirudin treated subjects
danaparoid	danaparoid	danaparoid treated subjects
argatroban	argatroban	argatroban treated subjects

Primary Outcome Measures

Name	Time	Method
Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II	19 January 2005 to 25 October 2009	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).

Secondary Outcome Measures

Name	Time	Method
Number of Participants Diagnosed With Bleeding After the Occurrence of HIT II	19 January 2005 to 25 October 2009	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.
Number of Participants With Fatal Complications After the Occurrence of HIT II	19 January 2005 to 25 October 2009	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.
Number of Participants Who Underwent Amputation After the Occurrence of HIT II	19 January 2005 to 25 October 2009	Participants' medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs).
Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II	19 January 2005 to 25 October 2009	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.
Number of Participants Who Experienced Skin Changes (Erythema and Necrosis) After the Occurrence of HIT II	19 January 2005 to 25 October 2009	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.