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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lepirudin | lepirudin treated subjects |
| |
| danaparoid | danaparoid treated subjects |
| |
| argatroban | argatroban treated subjects |
| |
| fondaparinux | fondaparinux treated subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lepirudin | Drug | lepirudin |
| |
| danaparoid |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Diagnosed With Bleeding After the Occurrence of HIT II | 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. | 19 January 2005 to 25 October 2009 |
| Number of Participants With Fatal Complications After the Occurrence of HIT II |
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Inclusion Criteria:
Exclusion Criteria:
-
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Hospitalized patients with HIT
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29169470 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Argatroban | Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II) |
| FG001 | Lepirudin | Participants treated with lepirudin after HIT II |
| FG002 | Danaparoid | Participants treated with danaparoid after HIT II |
| FG003 | Fondaparinux | Participants treated with fondaparinux after HIT II |
| FG004 | Argatroban/Fondaparinux | Participants treated with argatroban and fondaparinux after HIT II |
| FG005 | Danaparoid/Argatroban | Participants treated with danaparoid and argatroban after HIT II |
| FG006 | Danaparoid/Fondaparinux | Participants treated with danaparoid and fondaparinux after HIT II |
| FG007 | Danaparoid/Lepirudin | Participants treated with danaparoid and lepirudin after HIT II |
| FG008 | Danaparoid/Fondaparinux/Lepirudin | Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II |
| FG009 | Argatroban/Danaparoid/Fondaparinux | Participants treated with argatroban, danaparoid, and fondaparinux after HIT II |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Argatroban | Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II) |
| BG001 | Lepirudin | Participants treated with lepirudin after HIT II |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | 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. | Posted | Number | participants | 19 January 2005 to 25 October 2009 |
|
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This is a retrospective study of pre-existing medical record data; thus, no assessments of serious or non-serious adverse events are possible.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Argatroban | Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II) |
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Due to the retrospective nature of the data collection in this study, it is impossible to be precise about dose and frequency of dosing.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Cente | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| C083544 | lepirudin |
| C035838 | danaparoid |
| C031942 | argatroban |
| D000077425 | Fondaparinux |
| ID | Term |
|---|---|
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Drug |
danaparoid |
|
| argatroban | Drug | argatroban |
|
| fondaparinux | Drug | fondaparinux |
|
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. |
| 19 January 2005 to 25 October 2009 |
| Number of Participants Who Underwent Amputation After the Occurrence of HIT II | 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 |
| Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II | 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. | 19 January 2005 to 25 October 2009 |
| Number of Participants Who Experienced Skin Changes (Erythema and Necrosis) After the Occurrence of HIT II | 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. | 19 January 2005 to 25 October 2009 |
| BG002 | Danaparoid | Participants treated with danaparoid after HIT II |
| BG003 | Fondaparinux | Participants treated with fondaparinux after HIT II |
| BG004 | Argatroban/Fondaparinux | Participants treated with argatroban and fondaparinux after HIT II |
| BG005 | Danaparoid/Argatroban | Participants treated with danaparoid and argatroban after HIT II |
| BG006 | Danaparoid/Fondaparinux | Participants treated with danaparoid and fondaparinux after HIT II |
| BG007 | Danaparoid/Lepirudin | Participants treated with danaparoid and lepirudin after HIT II |
| BG008 | Danaparoid/Fondaparinux/Lepirudin | Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II |
| BG009 | Argatroban/Danaparoid/Fondaparinux | Participants treated with argatroban, danaparoid, and fondaparinux after HIT II |
| BG010 | Total | Total of all reporting groups |
| Years |
|
| Sex/Gender, Customized | Gender information is missing in one participant in the lepirudin arm. | Number | Participants |
|
| Number of participants receiving the indicated heparin treatment prior to HIT II | Number | participants |
|
| Number of participants receiving the indicated AT before HIT II with regard to rationale | 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 | participants |
|
| Number of participants receving the indicated AT before HIT II (specified) with regard to rationale | Multiple responses are possible. AT, anticoagulant treatment. | Number | participants |
|
| Number of participants with the indicated thromboembolic therapy (specified) | Multiple responses are possible. | Number | participants |
|
| OG001 | Lepirudin | Participants treated with lepirudin after HIT II |
| OG002 | Danaparoid | Participants treated with danaparoid after HIT II |
| OG003 | Fondaparinux | Participants treated with fondaparinux after HIT II |
| OG004 | Argatroban/Fondaparinux | Participants treated with argatroban and fondaparinux after HIT II |
| OG005 | Danaparoid/Argatroban | Participants treated with danaparoid and argatroban after HIT II |
| OG006 | Danaparoid/Fondaparinux | Participants treated with danaparoid and fondaparinux after HIT II |
| OG007 | Danaparoid/Lepirudin | Participants treated with danaparoid and lepirudin after HIT II |
| OG008 | Danaparoid/Fondaparinux/Lepirudin | Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II |
| OG009 | Argatroban/Danaparoid/Fondaparinux | Participants treated with argatroban, danaparoid, and fondaparinux after HIT II |
|
|
| Secondary | Number of Participants Diagnosed With Bleeding After the Occurrence of HIT II | 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. | 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. | Posted | Number | participants | 19 January 2005 to 25 October 2009 |
|
|
|
| Secondary | Number of Participants With Fatal Complications After the Occurrence of HIT II | 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. | 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. | Posted | Number | participants | 19 January 2005 to 25 October 2009 |
|
|
|
| Secondary | Number of Participants Who Underwent Amputation After the Occurrence of HIT II | Participants' medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs). | 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. | Posted | Number | participants | 19 January 2005 to 25 October 2009 |
|
|
|
| Secondary | Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II | 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. | 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. | Posted | Number | participants | 19 January 2005 to 25 October 2009 |
|
|
|
| Secondary | Number of Participants Who Experienced Skin Changes (Erythema and Necrosis) After the Occurrence of HIT II | 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. | 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. | Posted | Number | participants | 19 January 2005 to 25 October 2009 |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Lepirudin | Participants treated with lepirudin after HIT II | 0 | 0 | 0 | 0 |
| EG002 | Danaparoid | Participants treated with danaparoid after HIT II | 0 | 0 | 0 | 0 |
| EG003 | Fondaparinux | Participants treated with fondaparinux after HIT II | 0 | 0 | 0 | 0 |
| EG004 | Argatroban/Fondaparinux | Participants treated with argatroban and fondaparinux after HIT II | 0 | 0 | 0 | 0 |
| EG005 | Danaparoid/Argatroban | Participants treated with danaparoid and argatroban after HIT II | 0 | 0 | 0 | 0 |
| EG006 | Danaparoid/Fondaparinux | Participants treated with danaparoid and fondaparinux after HIT II | 0 | 0 | 0 | 0 |
| EG007 | Danaparoid/Lepirudin | Participants treated with danaparoid and lepirudin after HIT II | 0 | 0 | 0 | 0 |
| EG008 | Danaparoid/Fondaparinux/Lepirudin | Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II | 0 | 0 | 0 | 0 |
| EG009 | Argatroban/Danaparoid/Fondaparinux | Participants treated with argatroban, danaparoid, and fondaparinux after HIT II | 0 | 0 | 0 | 0 |
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.
| Bleeding |
|
| Fatal complication |
|
| Amputation |
|
| Persistent thrombocytopenia |
|
| No thrombocytopenia |
|
| Skin changes |
|