Acute HIT II (Heparin-induced Thrombocytopenia Type II) Clinical Trial
Official title:
Systematische Dokumentation Von Patienten Mit Akutem HIT-Verdacht
| Verified date | January 2011 |
| Source | GlaxoSmithKline |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Ethikkommission der Bayrischen Landesärztekammer |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 195 |
| Est. completion date | January 2010 |
| Est. primary completion date | January 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Acute HIT II (Heparin-induced Thrombocytopenia type II), 4T-Score - Treatment of HIT with Lepirudin, Danaparoid, Argatroban or Fondaparinux Exclusion Criteria: |
Observational Model: Cohort, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | 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). | 19 January 2005 to 25 October 2009 | No |
| Secondary | Number of Participants Diagnosed With Bleeding After the Occurrence of HIT II | 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. | 19 January 2005 to 25 October 2009 | No |
| Secondary | Number of Participants With Fatal Complications After the Occurrence of HIT II | 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. | 19 January 2005 to 25 October 2009 | No |
| Secondary | Number of Participants Who Underwent Amputation After the Occurrence of HIT II | Participants' medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs). | 19 January 2005 to 25 October 2009 | No |
| Secondary | Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II | 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. | 19 January 2005 to 25 October 2009 | No |
| Secondary | Number of Participants Who Experienced Skin Changes (Erythema and Necrosis) After the Occurrence of HIT II | 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. | 19 January 2005 to 25 October 2009 | No |