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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
Enrollment 195
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Argatroban Lepirudin Danaparoid Fondaparinux Argatroban/Fondaparinux Danaparoid/Argatroban Danaparoid/Fondaparinux Danaparoid/Lepirudin Danaparoid/Fondaparinux/Lepirudin Argatroban/Danaparoid/Fondaparinux
Hide Arm/Group Description Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II) Participants treated with lepirudin after HIT II Participants treated with danaparoid after HIT II Participants treated with fondaparinux after HIT II Participants treated with argatroban and fondaparinux after HIT II Participants treated with danaparoid and argatroban after HIT II Participants treated with danaparoid and fondaparinux after HIT II Participants treated with danaparoid and lepirudin after HIT II Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
Period Title: Overall Study
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
Arm/Group Title Argatroban Lepirudin Danaparoid Fondaparinux Argatroban/Fondaparinux Danaparoid/Argatroban Danaparoid/Fondaparinux Danaparoid/Lepirudin Danaparoid/Fondaparinux/Lepirudin Argatroban/Danaparoid/Fondaparinux Total
Hide Arm/Group Description Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II) Participants treated with lepirudin after HIT II Participants treated with danaparoid after HIT II Participants treated with fondaparinux after HIT II Participants treated with argatroban and fondaparinux after HIT II Participants treated with danaparoid and argatroban after HIT II Participants treated with danaparoid and fondaparinux after HIT II Participants treated with danaparoid and lepirudin after HIT II Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II Participants treated with argatroban, danaparoid, and fondaparinux after HIT II Total of all reporting groups
Overall Number of Baseline Participants 32 4 46 78 11 11 5 4 1 3 195
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants 4 participants 46 participants 78 participants 11 participants 11 participants 5 participants 4 participants 1 participants 3 participants 195 participants
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] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 32 participants 4 participants 46 participants 78 participants 11 participants 11 participants 5 participants 4 participants 1 participants 3 participants 195 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]
Measure Description: Gender information is missing in one participant in the lepirudin arm.
Number of participants receiving the indicated heparin treatment prior to HIT II  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 32 participants 4 participants 46 participants 78 participants 11 participants 11 participants 5 participants 4 participants 1 participants 3 participants 195 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] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 32 participants 4 participants 46 participants 78 participants 11 participants 11 participants 5 participants 4 participants 1 participants 3 participants 195 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]
Measure Description: 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] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 32 participants 4 participants 46 participants 78 participants 11 participants 11 participants 5 participants 4 participants 1 participants 3 participants 195 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]
Measure Description: Multiple responses are possible. AT, anticoagulant treatment.
Number of participants with the indicated thromboembolic therapy (specified)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 32 participants 4 participants 46 participants 78 participants 11 participants 11 participants 5 participants 4 participants 1 participants 3 participants 195 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]
Measure Description: Multiple responses are possible.
1.Primary Outcome
Title Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II
Hide Description 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).
Time Frame 19 January 2005 to 25 October 2009
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All documented participants diagnosed with suspected acute HIT II and a 4T Score of ≥4 who had received at least one dose of argatroban, lepirudin, danaparoid, or fondaparinux. The 4T score (range: 0-8) was developed to predict the probability of HIT.
Arm/Group Title Argatroban Lepirudin Danaparoid Fondaparinux Argatroban/Fondaparinux Danaparoid/Argatroban Danaparoid/Fondaparinux Danaparoid/Lepirudin Danaparoid/Fondaparinux/Lepirudin Argatroban/Danaparoid/Fondaparinux
Hide Arm/Group Description:
Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
Participants treated with lepirudin after HIT II
Participants treated with danaparoid after HIT II
Participants treated with fondaparinux after HIT II
Participants treated with argatroban and fondaparinux after HIT II
Participants treated with danaparoid and argatroban after HIT II
Participants treated with danaparoid and fondaparinux after HIT II
Participants treated with danaparoid and lepirudin after HIT II
Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
Overall Number of Participants Analyzed 32 4 46 78 11 11 5 4 1 3
Measure Type: Number
Unit of Measure: participants
Thrombosis 31 4 45 78 11 6 5 1 1 3
No thrombosis or pulmonary embolism 1 0 1 0 0 4 0 2 0 0
Pulmonary embolism 0 0 0 0 0 1 0 1 0 0
Thrombosis and pulmonary embolism 0 0 0 0 0 0 0 0 0 0
Unknown 0 0 0 0 0 0 0 0 0 0
2.Secondary Outcome
Title Number of Participants Diagnosed With Bleeding After the Occurrence of HIT II
Hide Description 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.
Time Frame 19 January 2005 to 25 October 2009
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All documented participants diagnosed with suspected acute HIT II and a 4T Score of ≥4 who had received at least one dose of argatroban, lepirudin, danaparoid, or fondaparinux. The 4T score (range: 0-8) was developed to predict the probability of HIT.
Arm/Group Title Argatroban Lepirudin Danaparoid Fondaparinux Argatroban/Fondaparinux Danaparoid/Argatroban Danaparoid/Fondaparinux Danaparoid/Lepirudin Danaparoid/Fondaparinux/Lepirudin Argatroban/Danaparoid/Fondaparinux
Hide Arm/Group Description:
Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
Participants treated with lepirudin after HIT II
Participants treated with danaparoid after HIT II
Participants treated with fondaparinux after HIT II
Participants treated with argatroban and fondaparinux after HIT II
Participants treated with danaparoid and argatroban after HIT II
Participants treated with danaparoid and fondaparinux after HIT II
Participants treated with danaparoid and lepirudin after HIT II
Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
Overall Number of Participants Analyzed 32 4 46 78 11 11 5 4 1 3
Measure Type: Number
Unit of Measure: participants
No Bleeding 30 4 43 74 11 8 5 2 1 3
Bleeding 2 0 3 4 0 3 0 2 0 0
3.Secondary Outcome
Title Number of Participants With Fatal Complications After the Occurrence of HIT II
Hide Description 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.
Time Frame 19 January 2005 to 25 October 2009
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All documented participants diagnosed with suspected acute HIT II and a 4T Score of ≥4 who had received at least one dose of argatroban, lepirudin, danaparoid, or fondaparinux. The 4T score (range: 0-8) was developed to predict the probability of HIT.
Arm/Group Title Argatroban Lepirudin Danaparoid Fondaparinux Argatroban/Fondaparinux Danaparoid/Argatroban Danaparoid/Fondaparinux Danaparoid/Lepirudin Danaparoid/Fondaparinux/Lepirudin Argatroban/Danaparoid/Fondaparinux
Hide Arm/Group Description:
Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
Participants treated with lepirudin after HIT II
Participants treated with danaparoid after HIT II
Participants treated with fondaparinux after HIT II
Participants treated with argatroban and fondaparinux after HIT II
Participants treated with danaparoid and argatroban after HIT II
Participants treated with danaparoid and fondaparinux after HIT II
Participants treated with danaparoid and lepirudin after HIT II
Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
Overall Number of Participants Analyzed 32 4 46 78 11 11 5 4 1 3
Measure Type: Number
Unit of Measure: participants
No fatal complication 27 4 35 78 11 9 5 2 1 3
Fatal complication 5 0 11 0 0 2 0 2 0 0
4.Secondary Outcome
Title Number of Participants Who Underwent Amputation After the Occurrence of HIT II
Hide Description Participants’ medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs).
Time Frame 19 January 2005 to 25 October 2009
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All documented participants diagnosed with suspected acute HIT II and a 4T Score of ≥4 who had received at least one dose of argatroban, lepirudin, danaparoid, or fondaparinux. The 4T score (range: 0-8) was developed to predict the probability of HIT.
Arm/Group Title Argatroban Lepirudin Danaparoid Fondaparinux Argatroban/Fondaparinux Danaparoid/Argatroban Danaparoid/Fondaparinux Danaparoid/Lepirudin Danaparoid/Fondaparinux/Lepirudin Argatroban/Danaparoid/Fondaparinux
Hide Arm/Group Description:
Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
Participants treated with lepirudin after HIT II
Participants treated with danaparoid after HIT II
Participants treated with fondaparinux after HIT II
Participants treated with argatroban and fondaparinux after HIT II
Participants treated with danaparoid and argatroban after HIT II
Participants treated with danaparoid and fondaparinux after HIT II
Participants treated with danaparoid and lepirudin after HIT II
Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
Overall Number of Participants Analyzed 32 4 46 78 11 11 5 4 1 3
Measure Type: Number
Unit of Measure: participants
No amputation 32 4 46 78 11 10 5 3 1 3
Amputation 0 0 0 0 0 1 0 1 0 0
5.Secondary Outcome
Title Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II
Hide Description 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.
Time Frame 19 January 2005 to 25 October 2009
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All documented participants diagnosed with suspected acute HIT II and a 4T Score of ≥4 who had received at least one dose of argatroban, lepirudin, danaparoid, or fondaparinux. The 4T score (range: 0-8) was developed to predict the probability of HIT.
Arm/Group Title Argatroban Lepirudin Danaparoid Fondaparinux Argatroban/Fondaparinux Danaparoid/Argatroban Danaparoid/Fondaparinux Danaparoid/Lepirudin Danaparoid/Fondaparinux/Lepirudin Argatroban/Danaparoid/Fondaparinux
Hide Arm/Group Description:
Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
Participants treated with lepirudin after HIT II
Participants treated with danaparoid after HIT II
Participants treated with fondaparinux after HIT II
Participants treated with argatroban and fondaparinux after HIT II
Participants treated with danaparoid and argatroban after HIT II
Participants treated with danaparoid and fondaparinux after HIT II
Participants treated with danaparoid and lepirudin after HIT II
Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
Overall Number of Participants Analyzed 32 4 46 78 11 11 5 4 3 1
Measure Type: Number
Unit of Measure: participants
Recurrent thrombocytopenia 0 0 1 0 0 3 0 1 0 0
Persistent thrombocytopenia 1 0 1 0 0 0 0 0 0 2
No thrombocytopenia 31 4 44 78 11 8 5 3 1 1
6.Secondary Outcome
Title Number of Participants Who Experienced Skin Changes (Erythema and Necrosis) After the Occurrence of HIT II
Hide Description 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.
Time Frame 19 January 2005 to 25 October 2009
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All documented participants diagnosed with suspected acute HIT II and a 4T Score of ≥4 who had received at least one dose of argatroban, lepirudin, danaparoid, or fondaparinux. The 4T score (range: 0-8) was developed to predict the probability of HIT.
Arm/Group Title Argatroban Lepirudin Danaparoid Fondaparinux Argatroban/Fondaparinux Danaparoid/Argatroban Danaparoid/Fondaparinux Danaparoid/Lepirudin Danaparoid/Fondaparinux/Lepirudin Argatroban/Danaparoid/Fondaparinux
Hide Arm/Group Description:
Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
Participants treated with lepirudin after HIT II
Participants treated with danaparoid after HIT II
Participants treated with fondaparinux after HIT II
Participants treated with argatroban and fondaparinux after HIT II
Participants treated with danaparoid and argatroban after HIT II
Participants treated with danaparoid and fondaparinux after HIT II
Participants treated with danaparoid and lepirudin after HIT II
Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
Overall Number of Participants Analyzed 32 4 46 78 11 11 5 4 1 3
Measure Type: Number
Unit of Measure: participants
No skin changes 32 4 45 78 11 11 5 3 0 3
Skin changes 0 0 1 0 0 0 0 1 1 0
Time Frame [Not Specified]
Adverse Event Reporting Description This is a retrospective study of pre-existing medical record data; thus, no assessments of serious or non-serious adverse events are possible.
 
Arm/Group Title Argatroban Lepirudin Danaparoid Fondaparinux Argatroban/Fondaparinux Danaparoid/Argatroban Danaparoid/Fondaparinux Danaparoid/Lepirudin Danaparoid/Fondaparinux/Lepirudin Argatroban/Danaparoid/Fondaparinux
Hide Arm/Group Description Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II) Participants treated with lepirudin after HIT II Participants treated with danaparoid after HIT II Participants treated with fondaparinux after HIT II Participants treated with argatroban and fondaparinux after HIT II Participants treated with danaparoid and argatroban after HIT II Participants treated with danaparoid and fondaparinux after HIT II Participants treated with danaparoid and lepirudin after HIT II Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
All-Cause Mortality
Argatroban Lepirudin Danaparoid Fondaparinux Argatroban/Fondaparinux Danaparoid/Argatroban Danaparoid/Fondaparinux Danaparoid/Lepirudin Danaparoid/Fondaparinux/Lepirudin Argatroban/Danaparoid/Fondaparinux
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Argatroban Lepirudin Danaparoid Fondaparinux Argatroban/Fondaparinux Danaparoid/Argatroban Danaparoid/Fondaparinux Danaparoid/Lepirudin Danaparoid/Fondaparinux/Lepirudin Argatroban/Danaparoid/Fondaparinux
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0   0/0   0/0   0/0   0/0   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Argatroban Lepirudin Danaparoid Fondaparinux Argatroban/Fondaparinux Danaparoid/Argatroban Danaparoid/Fondaparinux Danaparoid/Lepirudin Danaparoid/Fondaparinux/Lepirudin Argatroban/Danaparoid/Fondaparinux
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0   0/0   0/0   0/0   0/0   0/0   0/0 
Due to the retrospective nature of the data collection in this study, it is impossible to be precise about dose and frequency of dosing.
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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Cente
Organization: GlaxoSmithKline
Phone: 866-435-7343
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