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

NCT ID: NCT01304238

Last Updated: 2017-07-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

195 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute HIT II (Heparin-induced Thrombocytopenia Type II)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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lepirudin

lepirudin treated subjects

lepirudin

Intervention Type DRUG

lepirudin

danaparoid

danaparoid treated subjects

danaparoid

Intervention Type DRUG

danaparoid

argatroban

argatroban treated subjects

argatroban

Intervention Type DRUG

argatroban

fondaparinux

fondaparinux treated subjects

fondaparinux

Intervention Type DRUG

fondaparinux

Interventions

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lepirudin

lepirudin

Intervention Type DRUG

danaparoid

danaparoid

Intervention Type DRUG

argatroban

argatroban

Intervention Type DRUG

fondaparinux

fondaparinux

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

References

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Schindewolf M, Steindl J, Beyer-Westendorf J, Schellong S, Dohmen PM, Brachmann J, Madlener K, Potzsch B, Klamroth R, Hankowitz J, Banik N, Eberle S, Muller 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.

Reference Type DERIVED
PMID: 29169470 (View on PubMed)

Other Identifiers

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108745

Identifier Type: -

Identifier Source: org_study_id

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