Last updated: 11/03/2018 10:06:39

Retrospective registry of patients with acute Heparin-induced Thrombocytopenia type II

GSK study ID
108745
See study documents
Clinicaltrials.gov ID
NCT01304238
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Systematische Dokumentation von Patienten mit akutem HIT-Verdacht
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of Participants Diagnosed with Thrombosis and/or Pulmonary Embolism after the occurrence of HIT II

Timeframe: 19 January 2005 to 25 October 2009

Secondary outcomes:

Number of Participants Diagnosed with Bleeding after the occurrence of HIT II

Timeframe: 19 January 2005 to 25 October 2009

Number of Participants with Fatal Complications after the occurrence of HIT II

Timeframe: 19 January 2005 to 25 October 2009

Number of Participants Who Underwent Amputation after the occurrence of HIT II

Timeframe: 19 January 2005 to 25 October 2009

Number of Participants Who Were Diagnosed with Thrombocytopenia (Recurrent of Persistent) after the occurrence of HIT II

Timeframe: 19 January 2005 to 25 October 2009

Number of Participants Who Experienced Skin Changes (erythema and necrosis) after the occurrence of HIT II

Timeframe: 19 January 2005 to 25 October 2009

Interventions:
  • Drug: lepirudin
  • Drug: danaparoid
  • Drug: argatroban
  • Drug: fondaparinux
    • Enrollment:
    195
    Primary completion date:
    2010-31-01
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Acute HIT II (Heparin-induced Thrombocytopenia type II)
    Product
    fondaparinux sodium
    Collaborators
    Not applicable
    Study date(s)
    February 2009 to June 2010
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Acute HIT II (Heparin-induced Thrombocytopenia type II), 4T-Score
    • Treatment of HIT with Lepirudin, Danaparoid, Argatroban or Fondaparinux
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Acute HIT II (Heparin-induced Thrombocytopenia type II), 4T-Score
    • Treatment of HIT with Lepirudin, Danaparoid, Argatroban or Fondaparinux

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2010-31-01
    Actual study completion date
    2010-23-06

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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