Acute HIT II (Heparin-induced Thrombocytopenia Type II)
Conditions
Keywords
Retrospective evaluation of patients with acute Heparin-induced Thrombocytopenia type II treated with Fondaparinux
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.
Interventions
Sponsors
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Acute HIT II (Heparin-induced Thrombocytopenia type II), 4T-Score * Treatment of HIT with Lepirudin, Danaparoid, Argatroban or Fondaparinux
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Diagnosed With Bleeding After the Occurrence of HIT II | 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. |
| Number of Participants With Fatal Complications After the Occurrence of HIT II | 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. |
| Number of Participants Who Underwent Amputation After the Occurrence of HIT II | 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). |
| Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II | 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. |
| Number of Participants Who Experienced Skin Changes (Erythema and Necrosis) After the Occurrence of HIT II | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Argatroban Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II) | 32 |
| Lepirudin Participants treated with lepirudin after HIT II | 4 |
| Danaparoid Participants treated with danaparoid after HIT II | 46 |
| Fondaparinux Participants treated with fondaparinux after HIT II | 78 |
| Argatroban/Fondaparinux Participants treated with argatroban and fondaparinux after HIT II | 11 |
| Danaparoid/Argatroban Participants treated with danaparoid and argatroban after HIT II | 11 |
| Danaparoid/Fondaparinux Participants treated with danaparoid and fondaparinux after HIT II | 5 |
| Danaparoid/Lepirudin Participants treated with danaparoid and lepirudin after HIT II | 4 |
| Danaparoid/Fondaparinux/Lepirudin Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II | 1 |
| Argatroban/Danaparoid/Fondaparinux Participants treated with argatroban, danaparoid, and fondaparinux after HIT II | 3 |
| Total | 195 |
Baseline characteristics
| Characteristic | Danaparoid | Argatroban | Total | Argatroban/Danaparoid/Fondaparinux | Danaparoid/Fondaparinux/Lepirudin | Danaparoid/Lepirudin | Danaparoid/Fondaparinux | Danaparoid/Argatroban | Argatroban/Fondaparinux | Fondaparinux | Lepirudin |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 67.8 Years STANDARD_DEVIATION 13 | 66.4 Years STANDARD_DEVIATION 12.3 | 68.5 Years STANDARD_DEVIATION 12.5 | 63.7 Years STANDARD_DEVIATION 7.5 | 56.0 Years STANDARD_DEVIATION 0 | 55.3 Years STANDARD_DEVIATION 16 | 71.0 Years STANDARD_DEVIATION 8.6 | 60.0 Years STANDARD_DEVIATION 14 | 71.5 Years STANDARD_DEVIATION 12.1 | 71.7 Years STANDARD_DEVIATION 11.4 | 61.8 Years STANDARD_DEVIATION 13.7 |
| Number of participants receiving the indicated AT before HIT II with regard to rationale Prophylactic | 39 participants | 24 participants | 155 participants | 2 participants | 0 participants | 3 participants | 2 participants | 8 participants | 9 participants | 66 participants | 2 participants |
| Number of participants receiving the indicated AT before HIT II with regard to rationale Therapeutic | 18 participants | 14 participants | 76 participants | 3 participants | 1 participants | 2 participants | 3 participants | 6 participants | 6 participants | 21 participants | 2 participants |
| Number of participants receiving the indicated heparin treatment prior to HIT II Only low molecular weight heparin (LMWH) | 10 participants | 2 participants | 24 participants | 1 participants | 1 participants | 2 participants | 3 participants | 0 participants | 1 participants | 3 participants | 1 participants |
| Number of participants receiving the indicated heparin treatment prior to HIT II Only unfractionated heparin (UFH) | 24 participants | 19 participants | 109 participants | 1 participants | 0 participants | 0 participants | 1 participants | 7 participants | 3 participants | 53 participants | 1 participants |
| Number of participants receiving the indicated heparin treatment prior to HIT II UFH and LMWH | 12 participants | 11 participants | 62 participants | 1 participants | 0 participants | 2 participants | 1 participants | 4 participants | 7 participants | 22 participants | 2 participants |
| Number of participants receving the indicated AT before HIT II (specified) with regard to rationale Indication for thromboembolic therapy | 18 participants | 14 participants | 76 participants | 3 participants | 1 participants | 2 participants | 3 participants | 6 participants | 6 participants | 21 participants | 2 participants |
| Number of participants receving the indicated AT before HIT II (specified) with regard to rationale Prophylaxis: Internal Medicine | 27 participants | 13 participants | 55 participants | 2 participants | 0 participants | 1 participants | 1 participants | 5 participants | 2 participants | 4 participants | 0 participants |
| Number of participants receving the indicated AT before HIT II (specified) with regard to rationale Prophylaxis: Neurology/Neurosurgery | 10 participants | 2 participants | 14 participants | 0 participants | 0 participants | 0 participants | 1 participants | 0 participants | 1 participants | 0 participants | 0 participants |
| Number of participants receving the indicated AT before HIT II (specified) with regard to rationale Prophylaxis (no further specification) | 0 participants | 2 participants | 5 participants | 0 participants | 0 participants | 0 participants | 0 participants | 1 participants | 1 participants | 1 participants | 0 participants |
| Number of participants receving the indicated AT before HIT II (specified) with regard to rationale Prophylaxis: Surgery | 11 participants | 12 participants | 102 participants | 0 participants | 0 participants | 3 participants | 1 participants | 5 participants | 6 participants | 62 participants | 2 participants |
| Number of participants with the indicated thromboembolic therapy (specified) Acute coronary syndrome | 3 participants | 1 participants | 12 participants | 0 participants | 0 participants | 1 participants | 0 participants | 2 participants | 0 participants | 4 participants | 1 participants |
| Number of participants with the indicated thromboembolic therapy (specified) Alternative anticoagulation in atrial fibrillation | 9 participants | 4 participants | 31 participants | 2 participants | 0 participants | 0 participants | 2 participants | 0 participants | 1 participants | 13 participants | 0 participants |
| Number of participants with the indicated thromboembolic therapy (specified) Alternative anticoagulation in cardiac valve | 0 participants | 1 participants | 4 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 3 participants | 0 participants |
| Number of participants with the indicated thromboembolic therapy (specified) Deep vein thrombosis | 2 participants | 5 participants | 14 participants | 1 participants | 0 participants | 0 participants | 0 participants | 2 participants | 2 participants | 2 participants | 0 participants |
| Number of participants with the indicated thromboembolic therapy (specified) Other | 3 participants | 3 participants | 14 participants | 0 participants | 1 participants | 0 participants | 0 participants | 4 participants | 2 participants | 0 participants | 1 participants |
| Number of participants with the indicated thromboembolic therapy (specified) Peripheral artery occlusive disease | 1 participants | 0 participants | 3 participants | 0 participants | 0 participants | 0 participants | 1 participants | 0 participants | 0 participants | 1 participants | 0 participants |
| Number of participants with the indicated thromboembolic therapy (specified) Pulmonary embolism | 1 participants | 4 participants | 12 participants | 1 participants | 0 participants | 1 participants | 0 participants | 1 participants | 3 participants | 1 participants | 0 participants |
| Sex/Gender, Customized Female | 21 Participants | 10 Participants | 84 Participants | 2 Participants | 1 Participants | 2 Participants | 2 Participants | 5 Participants | 5 Participants | 35 Participants | 1 Participants |
| Sex/Gender, Customized Male | 25 Participants | 22 Participants | 110 Participants | 1 Participants | 0 Participants | 2 Participants | 3 Participants | 6 Participants | 6 Participants | 43 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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).
Time frame: 19 January 2005 to 25 October 2009
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Argatroban | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | Thrombosis and pulmonary embolism | 0 participants |
| Argatroban | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | Unknown | 0 participants |
| Argatroban | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | Thrombosis | 31 participants |
| Argatroban | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | Pulmonary embolism | 0 participants |
| Argatroban | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | No thrombosis or pulmonary embolism | 1 participants |
| Lepirudin | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | No thrombosis or pulmonary embolism | 0 participants |
| Lepirudin | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | Unknown | 0 participants |
| Lepirudin | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | Pulmonary embolism | 0 participants |
| Lepirudin | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | Thrombosis | 4 participants |
| Lepirudin | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | Thrombosis and pulmonary embolism | 0 participants |
| Danaparoid | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | Unknown | 0 participants |
| Danaparoid | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | Pulmonary embolism | 0 participants |
| Danaparoid | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | Thrombosis and pulmonary embolism | 0 participants |
| Danaparoid | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | No thrombosis or pulmonary embolism | 1 participants |
| Danaparoid | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | Thrombosis | 45 participants |
| Fondaparinux | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | Pulmonary embolism | 0 participants |
| Fondaparinux | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | Thrombosis | 78 participants |
| Fondaparinux | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | No thrombosis or pulmonary embolism | 0 participants |
| Fondaparinux | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | Thrombosis and pulmonary embolism | 0 participants |
| Fondaparinux | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | Unknown | 0 participants |
| Argatroban/Fondaparinux | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | No thrombosis or pulmonary embolism | 0 participants |
| Argatroban/Fondaparinux | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | Pulmonary embolism | 0 participants |
| Argatroban/Fondaparinux | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | Thrombosis | 11 participants |
| Argatroban/Fondaparinux | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | Thrombosis and pulmonary embolism | 0 participants |
| Argatroban/Fondaparinux | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | Unknown | 0 participants |
| Danaparoid/Argatroban | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | Thrombosis and pulmonary embolism | 0 participants |
| Danaparoid/Argatroban | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | Thrombosis | 6 participants |
| Danaparoid/Argatroban | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | Pulmonary embolism | 1 participants |
| Danaparoid/Argatroban | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | No thrombosis or pulmonary embolism | 4 participants |
| Danaparoid/Argatroban | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | Unknown | 0 participants |
| Danaparoid/Fondaparinux | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | Thrombosis | 5 participants |
| Danaparoid/Fondaparinux | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | Unknown | 0 participants |
| Danaparoid/Fondaparinux | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | Pulmonary embolism | 0 participants |
| Danaparoid/Fondaparinux | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | Thrombosis and pulmonary embolism | 0 participants |
| Danaparoid/Fondaparinux | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | No thrombosis or pulmonary embolism | 0 participants |
| Danaparoid/Lepirudin | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | Pulmonary embolism | 1 participants |
| Danaparoid/Lepirudin | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | Unknown | 0 participants |
| Danaparoid/Lepirudin | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | No thrombosis or pulmonary embolism | 2 participants |
| Danaparoid/Lepirudin | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | Thrombosis and pulmonary embolism | 0 participants |
| Danaparoid/Lepirudin | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | Thrombosis | 1 participants |
| Danaparoid/Fondaparinux/Lepirudin | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | Unknown | 0 participants |
| Danaparoid/Fondaparinux/Lepirudin | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | Thrombosis and pulmonary embolism | 0 participants |
| Danaparoid/Fondaparinux/Lepirudin | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | No thrombosis or pulmonary embolism | 0 participants |
| Danaparoid/Fondaparinux/Lepirudin | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | Pulmonary embolism | 0 participants |
| Danaparoid/Fondaparinux/Lepirudin | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | Thrombosis | 1 participants |
| Argatroban/Danaparoid/Fondaparinux | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | Pulmonary embolism | 0 participants |
| Argatroban/Danaparoid/Fondaparinux | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | Thrombosis and pulmonary embolism | 0 participants |
| Argatroban/Danaparoid/Fondaparinux | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | Thrombosis | 3 participants |
| Argatroban/Danaparoid/Fondaparinux | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | Unknown | 0 participants |
| Argatroban/Danaparoid/Fondaparinux | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II | No thrombosis or pulmonary embolism | 0 participants |
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.
Time frame: 19 January 2005 to 25 October 2009
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Argatroban | Number of Participants Diagnosed With Bleeding After the Occurrence of HIT II | No Bleeding | 30 participants |
| Argatroban | Number of Participants Diagnosed With Bleeding After the Occurrence of HIT II | Bleeding | 2 participants |
| Lepirudin | Number of Participants Diagnosed With Bleeding After the Occurrence of HIT II | Bleeding | 0 participants |
| Lepirudin | Number of Participants Diagnosed With Bleeding After the Occurrence of HIT II | No Bleeding | 4 participants |
| Danaparoid | Number of Participants Diagnosed With Bleeding After the Occurrence of HIT II | Bleeding | 3 participants |
| Danaparoid | Number of Participants Diagnosed With Bleeding After the Occurrence of HIT II | No Bleeding | 43 participants |
| Fondaparinux | Number of Participants Diagnosed With Bleeding After the Occurrence of HIT II | No Bleeding | 74 participants |
| Fondaparinux | Number of Participants Diagnosed With Bleeding After the Occurrence of HIT II | Bleeding | 4 participants |
| Argatroban/Fondaparinux | Number of Participants Diagnosed With Bleeding After the Occurrence of HIT II | No Bleeding | 11 participants |
| Argatroban/Fondaparinux | Number of Participants Diagnosed With Bleeding After the Occurrence of HIT II | Bleeding | 0 participants |
| Danaparoid/Argatroban | Number of Participants Diagnosed With Bleeding After the Occurrence of HIT II | Bleeding | 3 participants |
| Danaparoid/Argatroban | Number of Participants Diagnosed With Bleeding After the Occurrence of HIT II | No Bleeding | 8 participants |
| Danaparoid/Fondaparinux | Number of Participants Diagnosed With Bleeding After the Occurrence of HIT II | No Bleeding | 5 participants |
| Danaparoid/Fondaparinux | Number of Participants Diagnosed With Bleeding After the Occurrence of HIT II | Bleeding | 0 participants |
| Danaparoid/Lepirudin | Number of Participants Diagnosed With Bleeding After the Occurrence of HIT II | No Bleeding | 2 participants |
| Danaparoid/Lepirudin | Number of Participants Diagnosed With Bleeding After the Occurrence of HIT II | Bleeding | 2 participants |
| Danaparoid/Fondaparinux/Lepirudin | Number of Participants Diagnosed With Bleeding After the Occurrence of HIT II | No Bleeding | 1 participants |
| Danaparoid/Fondaparinux/Lepirudin | Number of Participants Diagnosed With Bleeding After the Occurrence of HIT II | Bleeding | 0 participants |
| Argatroban/Danaparoid/Fondaparinux | Number of Participants Diagnosed With Bleeding After the Occurrence of HIT II | No Bleeding | 3 participants |
| Argatroban/Danaparoid/Fondaparinux | Number of Participants Diagnosed With Bleeding After the Occurrence of HIT II | Bleeding | 0 participants |
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.
Time frame: 19 January 2005 to 25 October 2009
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Argatroban | Number of Participants Who Experienced Skin Changes (Erythema and Necrosis) After the Occurrence of HIT II | Skin changes | 0 participants |
| Argatroban | Number of Participants Who Experienced Skin Changes (Erythema and Necrosis) After the Occurrence of HIT II | No skin changes | 32 participants |
| Lepirudin | Number of Participants Who Experienced Skin Changes (Erythema and Necrosis) After the Occurrence of HIT II | Skin changes | 0 participants |
| Lepirudin | Number of Participants Who Experienced Skin Changes (Erythema and Necrosis) After the Occurrence of HIT II | No skin changes | 4 participants |
| Danaparoid | Number of Participants Who Experienced Skin Changes (Erythema and Necrosis) After the Occurrence of HIT II | Skin changes | 1 participants |
| Danaparoid | Number of Participants Who Experienced Skin Changes (Erythema and Necrosis) After the Occurrence of HIT II | No skin changes | 45 participants |
| Fondaparinux | Number of Participants Who Experienced Skin Changes (Erythema and Necrosis) After the Occurrence of HIT II | Skin changes | 0 participants |
| Fondaparinux | Number of Participants Who Experienced Skin Changes (Erythema and Necrosis) After the Occurrence of HIT II | No skin changes | 78 participants |
| Argatroban/Fondaparinux | Number of Participants Who Experienced Skin Changes (Erythema and Necrosis) After the Occurrence of HIT II | Skin changes | 0 participants |
| Argatroban/Fondaparinux | Number of Participants Who Experienced Skin Changes (Erythema and Necrosis) After the Occurrence of HIT II | No skin changes | 11 participants |
| Danaparoid/Argatroban | Number of Participants Who Experienced Skin Changes (Erythema and Necrosis) After the Occurrence of HIT II | No skin changes | 11 participants |
| Danaparoid/Argatroban | Number of Participants Who Experienced Skin Changes (Erythema and Necrosis) After the Occurrence of HIT II | Skin changes | 0 participants |
| Danaparoid/Fondaparinux | Number of Participants Who Experienced Skin Changes (Erythema and Necrosis) After the Occurrence of HIT II | No skin changes | 5 participants |
| Danaparoid/Fondaparinux | Number of Participants Who Experienced Skin Changes (Erythema and Necrosis) After the Occurrence of HIT II | Skin changes | 0 participants |
| Danaparoid/Lepirudin | Number of Participants Who Experienced Skin Changes (Erythema and Necrosis) After the Occurrence of HIT II | No skin changes | 3 participants |
| Danaparoid/Lepirudin | Number of Participants Who Experienced Skin Changes (Erythema and Necrosis) After the Occurrence of HIT II | Skin changes | 1 participants |
| Danaparoid/Fondaparinux/Lepirudin | Number of Participants Who Experienced Skin Changes (Erythema and Necrosis) After the Occurrence of HIT II | No skin changes | 0 participants |
| Danaparoid/Fondaparinux/Lepirudin | Number of Participants Who Experienced Skin Changes (Erythema and Necrosis) After the Occurrence of HIT II | Skin changes | 1 participants |
| Argatroban/Danaparoid/Fondaparinux | Number of Participants Who Experienced Skin Changes (Erythema and Necrosis) After the Occurrence of HIT II | Skin changes | 0 participants |
| Argatroban/Danaparoid/Fondaparinux | Number of Participants Who Experienced Skin Changes (Erythema and Necrosis) After the Occurrence of HIT II | No skin changes | 3 participants |
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).
Time frame: 19 January 2005 to 25 October 2009
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Argatroban | Number of Participants Who Underwent Amputation After the Occurrence of HIT II | No amputation | 32 participants |
| Argatroban | Number of Participants Who Underwent Amputation After the Occurrence of HIT II | Amputation | 0 participants |
| Lepirudin | Number of Participants Who Underwent Amputation After the Occurrence of HIT II | No amputation | 4 participants |
| Lepirudin | Number of Participants Who Underwent Amputation After the Occurrence of HIT II | Amputation | 0 participants |
| Danaparoid | Number of Participants Who Underwent Amputation After the Occurrence of HIT II | No amputation | 46 participants |
| Danaparoid | Number of Participants Who Underwent Amputation After the Occurrence of HIT II | Amputation | 0 participants |
| Fondaparinux | Number of Participants Who Underwent Amputation After the Occurrence of HIT II | No amputation | 78 participants |
| Fondaparinux | Number of Participants Who Underwent Amputation After the Occurrence of HIT II | Amputation | 0 participants |
| Argatroban/Fondaparinux | Number of Participants Who Underwent Amputation After the Occurrence of HIT II | Amputation | 0 participants |
| Argatroban/Fondaparinux | Number of Participants Who Underwent Amputation After the Occurrence of HIT II | No amputation | 11 participants |
| Danaparoid/Argatroban | Number of Participants Who Underwent Amputation After the Occurrence of HIT II | Amputation | 1 participants |
| Danaparoid/Argatroban | Number of Participants Who Underwent Amputation After the Occurrence of HIT II | No amputation | 10 participants |
| Danaparoid/Fondaparinux | Number of Participants Who Underwent Amputation After the Occurrence of HIT II | Amputation | 0 participants |
| Danaparoid/Fondaparinux | Number of Participants Who Underwent Amputation After the Occurrence of HIT II | No amputation | 5 participants |
| Danaparoid/Lepirudin | Number of Participants Who Underwent Amputation After the Occurrence of HIT II | No amputation | 3 participants |
| Danaparoid/Lepirudin | Number of Participants Who Underwent Amputation After the Occurrence of HIT II | Amputation | 1 participants |
| Danaparoid/Fondaparinux/Lepirudin | Number of Participants Who Underwent Amputation After the Occurrence of HIT II | No amputation | 1 participants |
| Danaparoid/Fondaparinux/Lepirudin | Number of Participants Who Underwent Amputation After the Occurrence of HIT II | Amputation | 0 participants |
| Argatroban/Danaparoid/Fondaparinux | Number of Participants Who Underwent Amputation After the Occurrence of HIT II | No amputation | 3 participants |
| Argatroban/Danaparoid/Fondaparinux | Number of Participants Who Underwent Amputation After the Occurrence of HIT II | Amputation | 0 participants |
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.
Time frame: 19 January 2005 to 25 October 2009
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Argatroban | Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II | Persistent thrombocytopenia | 1 participants |
| Argatroban | Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II | No thrombocytopenia | 31 participants |
| Argatroban | Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II | Recurrent thrombocytopenia | 0 participants |
| Lepirudin | Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II | Persistent thrombocytopenia | 0 participants |
| Lepirudin | Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II | Recurrent thrombocytopenia | 0 participants |
| Lepirudin | Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II | No thrombocytopenia | 4 participants |
| Danaparoid | Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II | No thrombocytopenia | 44 participants |
| Danaparoid | Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II | Recurrent thrombocytopenia | 1 participants |
| Danaparoid | Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II | Persistent thrombocytopenia | 1 participants |
| Fondaparinux | Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II | No thrombocytopenia | 78 participants |
| Fondaparinux | Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II | Recurrent thrombocytopenia | 0 participants |
| Fondaparinux | Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II | Persistent thrombocytopenia | 0 participants |
| Argatroban/Fondaparinux | Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II | Recurrent thrombocytopenia | 0 participants |
| Argatroban/Fondaparinux | Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II | No thrombocytopenia | 11 participants |
| Argatroban/Fondaparinux | Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II | Persistent thrombocytopenia | 0 participants |
| Danaparoid/Argatroban | Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II | Persistent thrombocytopenia | 0 participants |
| Danaparoid/Argatroban | Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II | No thrombocytopenia | 8 participants |
| Danaparoid/Argatroban | Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II | Recurrent thrombocytopenia | 3 participants |
| Danaparoid/Fondaparinux | Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II | Recurrent thrombocytopenia | 0 participants |
| Danaparoid/Fondaparinux | Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II | Persistent thrombocytopenia | 0 participants |
| Danaparoid/Fondaparinux | Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II | No thrombocytopenia | 5 participants |
| Danaparoid/Lepirudin | Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II | Persistent thrombocytopenia | 0 participants |
| Danaparoid/Lepirudin | Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II | Recurrent thrombocytopenia | 1 participants |
| Danaparoid/Lepirudin | Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II | No thrombocytopenia | 3 participants |
| Danaparoid/Fondaparinux/Lepirudin | Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II | Persistent thrombocytopenia | 0 participants |
| Danaparoid/Fondaparinux/Lepirudin | Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II | Recurrent thrombocytopenia | 0 participants |
| Danaparoid/Fondaparinux/Lepirudin | Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II | No thrombocytopenia | 1 participants |
| Argatroban/Danaparoid/Fondaparinux | Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II | Recurrent thrombocytopenia | 0 participants |
| Argatroban/Danaparoid/Fondaparinux | Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II | Persistent thrombocytopenia | 2 participants |
| Argatroban/Danaparoid/Fondaparinux | Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II | No thrombocytopenia | 1 participants |
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.
Time frame: 19 January 2005 to 25 October 2009
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Argatroban | Number of Participants With Fatal Complications After the Occurrence of HIT II | No fatal complication | 27 participants |
| Argatroban | Number of Participants With Fatal Complications After the Occurrence of HIT II | Fatal complication | 5 participants |
| Lepirudin | Number of Participants With Fatal Complications After the Occurrence of HIT II | Fatal complication | 0 participants |
| Lepirudin | Number of Participants With Fatal Complications After the Occurrence of HIT II | No fatal complication | 4 participants |
| Danaparoid | Number of Participants With Fatal Complications After the Occurrence of HIT II | Fatal complication | 11 participants |
| Danaparoid | Number of Participants With Fatal Complications After the Occurrence of HIT II | No fatal complication | 35 participants |
| Fondaparinux | Number of Participants With Fatal Complications After the Occurrence of HIT II | Fatal complication | 0 participants |
| Fondaparinux | Number of Participants With Fatal Complications After the Occurrence of HIT II | No fatal complication | 78 participants |
| Argatroban/Fondaparinux | Number of Participants With Fatal Complications After the Occurrence of HIT II | No fatal complication | 11 participants |
| Argatroban/Fondaparinux | Number of Participants With Fatal Complications After the Occurrence of HIT II | Fatal complication | 0 participants |
| Danaparoid/Argatroban | Number of Participants With Fatal Complications After the Occurrence of HIT II | No fatal complication | 9 participants |
| Danaparoid/Argatroban | Number of Participants With Fatal Complications After the Occurrence of HIT II | Fatal complication | 2 participants |
| Danaparoid/Fondaparinux | Number of Participants With Fatal Complications After the Occurrence of HIT II | No fatal complication | 5 participants |
| Danaparoid/Fondaparinux | Number of Participants With Fatal Complications After the Occurrence of HIT II | Fatal complication | 0 participants |
| Danaparoid/Lepirudin | Number of Participants With Fatal Complications After the Occurrence of HIT II | Fatal complication | 2 participants |
| Danaparoid/Lepirudin | Number of Participants With Fatal Complications After the Occurrence of HIT II | No fatal complication | 2 participants |
| Danaparoid/Fondaparinux/Lepirudin | Number of Participants With Fatal Complications After the Occurrence of HIT II | No fatal complication | 1 participants |
| Danaparoid/Fondaparinux/Lepirudin | Number of Participants With Fatal Complications After the Occurrence of HIT II | Fatal complication | 0 participants |
| Argatroban/Danaparoid/Fondaparinux | Number of Participants With Fatal Complications After the Occurrence of HIT II | No fatal complication | 3 participants |
| Argatroban/Danaparoid/Fondaparinux | Number of Participants With Fatal Complications After the Occurrence of HIT II | Fatal complication | 0 participants |