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OpenTrials
Completed

NCT Number: NCT01304238

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

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.

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Key information

Conditions

Acute HIT II (Heparin-induced Thrombocytopenia Type II)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

lepirudin

Drug

lepirudin

danaparoid

Drug

danaparoid

Argatroban

Drug

argatroban

fondaparinux

Drug

fondaparinux

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Systematische Dokumentation Von Patienten Mit Akutem HIT-Verdacht

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Feb 25, 2011
Registry last updated
Jul 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.