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

Overview

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.

Full Title of Study: “Systematische Dokumentation Von Patienten Mit Akutem HIT-Verdacht”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: January 2010

Interventions

  • Drug: lepirudin
    • lepirudin
  • Drug: danaparoid
    • danaparoid
  • Drug: argatroban
    • argatroban
  • Drug: fondaparinux
    • fondaparinux

Arms, Groups and Cohorts

  • lepirudin
    • lepirudin treated subjects
  • danaparoid
    • danaparoid treated subjects
  • argatroban
    • argatroban treated subjects
  • fondaparinux
    • fondaparinux treated subjects

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II
    • Time Frame: 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 Measures

  • Number of Participants Diagnosed With Bleeding After the Occurrence of HIT II
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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.

Participating in This Clinical Trial

Inclusion Criteria

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

    Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • GlaxoSmithKline
    • Provider of Information About this Clinical Study
      • Sponsor
    • Overall Official(s)
      • GSK Clinical Trials, Study Director, GlaxoSmithKline

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