N/A
N=195
Retrospective Registry of Patients With Acute Heparin-induced Thrombocytopenia Type II
Acute HIT II (Heparin-induced Thrombocytopenia Type II)
Bottom Line
View on ClinicalTrials.gov: NCT01304238 ↗Enrolled (actual)
195
Serious AEs
—
Results posted
Feb 2011
Primary outcome: Primary: Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II — 31; 4; 45; 78 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- lepirudin (Drug); danaparoid (Drug); argatroban (Drug); fondaparinux (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II |
31; 4; 45; 78; 11; 6 | — |
| SECONDARY Number of Participants Diagnosed With Bleeding After the Occurrence of HIT II |
30; 4; 43; 74; 11; 8 | — |
| SECONDARY Number of Participants With Fatal Complications After the Occurrence of HIT II |
27; 4; 35; 78; 11; 9 | — |
| SECONDARY Number of Participants Who Underwent Amputation After the Occurrence of HIT II |
32; 4; 46; 78; 11; 10 | — |
| SECONDARY Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II |
0; 0; 1; 0; 0; 3 | — |
| SECONDARY Number of Participants Who Experienced Skin Changes (Erythema and Necrosis) After the Occurrence of HIT II |
32; 4; 45; 78; 11; 11 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Acute HIT II (Heparin-induced Thrombocytopenia type II), 4T-Score
- Treatment of HIT with Lepirudin, Danaparoid, Argatroban or Fondaparinux
Exclusion Criteria
-
Data sourced from ClinicalTrials.gov (NCT01304238). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.