Last updated: 11/03/2018 10:06:39
Retrospective registry of patients with acute Heparin-induced Thrombocytopenia type II
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Cohort
Primary completion date:
2010-31-01
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)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
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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