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

• 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: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Study Description

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 Design

• 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

Groups and Cohorts

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

Outcome Measures

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.

Eligibility Criteria

• 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:

-

Contacts and Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Schindewolf M, Steindl J, Beyer-Westendorf J, Schellong S, Dohmen PM, Brachmann J, Madlener K, Pötzsch B, Klamroth R, Hankowitz J, Banik N, Eberle S, Müller MM, Kropff S, Lindhoff-Last E. Use of Fondaparinux Off-Label or Approved Anticoagulants for Management of Heparin-Induced Thrombocytopenia. J Am Coll Cardiol. 2017 Nov 28;70(21):2636-2648. doi: 10.1016/j.jacc.2017.09.1099.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT01304238
• Other Study ID Numbers: 108745
• First Posted: February 25, 2011
• 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; PENTA; Lepirudin; Danaparoid; Fondaparinux; Argatroban; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anticoagulants; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors