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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01304238
First received: January 27, 2011
Last updated: March 10, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention
Acute HIT II (Heparin-induced Thrombocytopenia Type II)
Drug: lepirudin
Drug: danaparoid
Drug: argatroban
Drug: fondaparinux

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Systematische Dokumentation Von Patienten Mit Akutem HIT-Verdacht

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Number of Participants Diagnosed With Bleeding After the Occurrence of HIT II [ Time Frame: 19 January 2005 to 25 October 2009 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 195
Study Start Date: February 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
lepirudin
lepirudin treated subjects
Drug: lepirudin
lepirudin
danaparoid
danaparoid treated subjects
Drug: danaparoid
danaparoid
argatroban
argatroban treated subjects
Drug: argatroban
argatroban
fondaparinux
fondaparinux treated subjects
Drug: fondaparinux
fondaparinux

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Hospitalized patients with HIT

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01304238

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01304238     History of Changes
Other Study ID Numbers: 108745
Study First Received: January 27, 2011
Results First Received: January 27, 2011
Last Updated: March 10, 2011
Health Authority: Germany: Ethikkommission der Bayrischen Landesärztekammer

Keywords provided by GlaxoSmithKline:
Retrospective evaluation of patients with acute Heparin-induced Thrombocytopenia type II treated with Fondaparinux

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases
Fondaparinux
PENTA
Danaproid
Lepirudin
Argatroban
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on October 01, 2014