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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

Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Retrospective
Condition: Acute HIT II (Heparin-induced Thrombocytopenia Type II)
Interventions: Drug: lepirudin
Drug: danaparoid
Drug: argatroban
Drug: fondaparinux

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Argatroban Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
Lepirudin Participants treated with lepirudin after HIT II
Danaparoid Participants treated with danaparoid after HIT II
Fondaparinux Participants treated with fondaparinux after HIT II
Argatroban/Fondaparinux Participants treated with argatroban and fondaparinux after HIT II
Danaparoid/Argatroban Participants treated with danaparoid and argatroban after HIT II
Danaparoid/Fondaparinux Participants treated with danaparoid and fondaparinux after HIT II
Danaparoid/Lepirudin Participants treated with danaparoid and lepirudin after HIT II
Danaparoid/Fondaparinux/Lepirudin Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
Argatroban/Danaparoid/Fondaparinux Participants treated with argatroban, danaparoid, and fondaparinux after HIT II

Participant Flow:   Overall Study
    Argatroban   Lepirudin   Danaparoid   Fondaparinux   Argatroban/Fondaparinux   Danaparoid/Argatroban   Danaparoid/Fondaparinux   Danaparoid/Lepirudin   Danaparoid/Fondaparinux/Lepirudin   Argatroban/Danaparoid/Fondaparinux
STARTED   32   4   46   78   11   11   5   4   1   3 
COMPLETED   32   4   46   78   11   11   5   4   1   3 
NOT COMPLETED   0   0   0   0   0   0   0   0   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Argatroban Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
Lepirudin Participants treated with lepirudin after HIT II
Danaparoid Participants treated with danaparoid after HIT II
Fondaparinux Participants treated with fondaparinux after HIT II
Argatroban/Fondaparinux Participants treated with argatroban and fondaparinux after HIT II
Danaparoid/Argatroban Participants treated with danaparoid and argatroban after HIT II
Danaparoid/Fondaparinux Participants treated with danaparoid and fondaparinux after HIT II
Danaparoid/Lepirudin Participants treated with danaparoid and lepirudin after HIT II
Danaparoid/Fondaparinux/Lepirudin Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
Argatroban/Danaparoid/Fondaparinux Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
Total Total of all reporting groups

Baseline Measures
   Argatroban   Lepirudin   Danaparoid   Fondaparinux   Argatroban/Fondaparinux   Danaparoid/Argatroban   Danaparoid/Fondaparinux   Danaparoid/Lepirudin   Danaparoid/Fondaparinux/Lepirudin   Argatroban/Danaparoid/Fondaparinux   Total 
Overall Participants Analyzed 
[Units: Participants]
 32   4   46   78   11   11   5   4   1   3   195 
Age 
[Units: Years]
Mean (Standard Deviation)
 66.4  (12.3)   61.8  (13.7)   67.8  (13.0)   71.7  (11.4)   71.5  (12.1)   60.0  (14.0)   71.0  (8.6)   55.3  (16.0)   56.0  (0.0)   63.7  (7.5)   68.5  (12.5) 
Sex/Gender, Customized [1] 
[Units: Participants]
                     
Female   10   1   21   35   5   5   2   2   1   2   84 
Male   22   2   25   43   6   6   3   2   0   1   110 
[1] Gender information is missing in one participant in the lepirudin arm.
Number of participants receiving the indicated heparin treatment prior to HIT II 
[Units: Participants]
                     
Only unfractionated heparin (UFH)   19   1   24   53   3   7   1   0   0   1   109 
Only low molecular weight heparin (LMWH)   2   1   10   3   1   0   3   2   1   1   24 
UFH and LMWH   11   2   12   22   7   4   1   2   0   1   62 
Number of participants receiving the indicated AT before HIT II with regard to rationale [1] 
[Units: Participants]
                     
Prophylactic   24   2   39   66   9   8   2   3   0   2   155 
Therapeutic   14   2   18   21   6   6   3   2   1   3   76 
[1] Multiple responses are possible. AT, anticoagulant treatment. “Rationale” refers to the initial reason for giving antithrombotics, e.g., for prophylaxis or for therapy of thrombosis.
Number of participants receving the indicated AT before HIT II (specified) with regard to rationale [1] 
[Units: Participants]
                     
Prophylaxis (no further specification)   2   0   0   1   1   1   0   0   0   0   5 
Prophylaxis: Surgery   12   2   11   62   6   5   1   3   0   0   102 
Prophylaxis: Internal Medicine   13   0   27   4   2   5   1   1   0   2   55 
Prophylaxis: Neurology/Neurosurgery   2   0   10   0   1   0   1   0   0   0   14 
Indication for thromboembolic therapy   14   2   18   21   6   6   3   2   1   3   76 
[1] Multiple responses are possible. AT, anticoagulant treatment.
Number of participants with the indicated thromboembolic therapy (specified) [1] 
[Units: Participants]
                     
Deep vein thrombosis   5   0   2   2   2   2   0   0   0   1   14 
Pulmonary embolism   4   0   1   1   3   1   0   1   0   1   12 
Peripheral artery occlusive disease   0   0   1   1   0   0   1   0   0   0   3 
Acute coronary syndrome   1   1   3   4   0   2   0   1   0   0   12 
Alternative anticoagulation in atrial fibrillation   4   0   9   13   1   0   2   0   0   2   31 
Alternative anticoagulation in cardiac valve   1   0   0   3   0   0   0   0   0   0   4 
Other   3   1   3   0   2   4   0   0   1   0   14 
[1] Multiple responses are possible.


  Outcome Measures

1.  Primary:   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 ]

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

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

4.  Secondary:   Number of Participants Who Underwent Amputation After the Occurrence of HIT II   [ Time Frame: 19 January 2005 to 25 October 2009 ]

5.  Secondary:   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 ]

6.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Due to the retrospective nature of the data collection in this study, it is impossible to be precise about dose and frequency of dosing.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Cente
Organization: GlaxoSmithKline
phone: 866-435-7343


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 Submitted: January 27, 2011
First Posted: February 25, 2011
Results First Submitted: January 27, 2011
Results First Posted: February 25, 2011
Last Update Posted: July 6, 2017