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

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ClinicalTrials.gov Identifier: NCT01304238
Recruitment Status : Completed
First Posted : February 25, 2011
Results First Posted : February 25, 2011
Last Update Posted : July 6, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief 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.

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

Study Type : Observational
Actual Enrollment : 195 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Systematische Dokumentation Von Patienten Mit Akutem HIT-Verdacht
Study Start Date : February 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]
    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 :
  1. Number of Participants Diagnosed With Bleeding After the Occurrence of HIT II [ Time Frame: 19 January 2005 to 25 October 2009 ]
    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.

  2. Number of Participants With Fatal Complications After the Occurrence of HIT II [ Time Frame: 19 January 2005 to 25 October 2009 ]
    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.

  3. Number of Participants Who Underwent Amputation After the Occurrence of HIT II [ Time Frame: 19 January 2005 to 25 October 2009 ]
    Participants' medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs).

  4. 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 ]
    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.

  5. 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 ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01304238


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01304238     History of Changes
Other Study ID Numbers: 108745
First Posted: February 25, 2011    Key Record Dates
Results First Posted: February 25, 2011
Last Update Posted: July 6, 2017
Last Verified: June 2017

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
Argatroban
Lepirudin
Danaproid
Heparin
Hirudins
Dermatan Sulfate
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Platelet Aggregation Inhibitors