NCT01304238

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
195

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2009

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2011

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 25, 2011

Completed
Same day until next milestone

Results Posted

Study results publicly available

February 25, 2011

Completed
Last Updated

July 6, 2017

Status Verified

June 1, 2017

Enrollment Period

11 months

First QC Date

January 27, 2011

Results QC Date

January 27, 2011

Last Update Submit

June 6, 2017

Conditions

Acute HIT II (Heparin-induced Thrombocytopenia Type II)

Keywords

Retrospective evaluation of patients with acute Heparin-induced Thrombocytopenia type II treated with Fondaparinux

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • Number of Participants Diagnosed With Bleeding After the Occurrence of HIT II

    19 January 2005 to 25 October 2009

  • Number of Participants With Fatal Complications After the Occurrence of HIT II

    19 January 2005 to 25 October 2009

  • Number of Participants Who Underwent Amputation After the Occurrence of HIT II

    19 January 2005 to 25 October 2009

  • Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II

    19 January 2005 to 25 October 2009

  • Number of Participants Who Experienced Skin Changes (Erythema and Necrosis) After the Occurrence of HIT II

    19 January 2005 to 25 October 2009

Study Arms (4)

lepirudin

lepirudin treated subjects

Drug: lepirudin

danaparoid

danaparoid treated subjects

Drug: danaparoid

argatroban

argatroban treated subjects

Drug: argatroban

fondaparinux

fondaparinux treated subjects

Drug: fondaparinux

Interventions

lepirudinDRUG

lepirudin

lepirudin
danaparoidDRUG

danaparoid

danaparoid
argatrobanDRUG

argatroban

argatroban
fondaparinuxDRUG

fondaparinux

fondaparinux

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hospitalized patients with HIT

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 29169470DERIVED

MeSH Terms

Interventions

lepirudindanaparoidargatrobanFondaparinux

Intervention Hierarchy (Ancestors)

OligosaccharidesPolysaccharidesCarbohydrates

Limitations and Caveats

Due to the retrospective nature of the data collection in this study, it is impossible to be precise about dose and frequency of dosing.

Results Point of Contact

Title
GSK Response Cente
Organization
GlaxoSmithKline
866-435-7343

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2011

First Posted

February 25, 2011

Study Start

February 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

July 6, 2017

Results First Posted

February 25, 2011

Record last verified: 2017-06