Trial Outcomes & Findings for Retrospective Registry of Patients With Acute Heparin-induced Thrombocytopenia Type II (NCT NCT01304238)
NCT ID: NCT01304238
Last Updated: 2017-07-06
Results Overview
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).
Recruitment status
COMPLETED
Target enrollment
195 participants
Primary outcome timeframe
19 January 2005 to 25 October 2009
Results posted on
2017-07-06
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
32
|
4
|
46
|
78
|
11
|
11
|
5
|
4
|
1
|
3
|
|
Overall Study
COMPLETED
|
32
|
4
|
46
|
78
|
11
|
11
|
5
|
4
|
1
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Retrospective Registry of Patients With Acute Heparin-induced Thrombocytopenia Type II
Baseline characteristics by cohort
| Measure |
Argatroban
n=32 Participants
Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
|
Lepirudin
n=4 Participants
Participants treated with lepirudin after HIT II
|
Danaparoid
n=46 Participants
Participants treated with danaparoid after HIT II
|
Fondaparinux
n=78 Participants
Participants treated with fondaparinux after HIT II
|
Argatroban/Fondaparinux
n=11 Participants
Participants treated with argatroban and fondaparinux after HIT II
|
Danaparoid/Argatroban
n=11 Participants
Participants treated with danaparoid and argatroban after HIT II
|
Danaparoid/Fondaparinux
n=5 Participants
Participants treated with danaparoid and fondaparinux after HIT II
|
Danaparoid/Lepirudin
n=4 Participants
Participants treated with danaparoid and lepirudin after HIT II
|
Danaparoid/Fondaparinux/Lepirudin
n=1 Participants
Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
|
Argatroban/Danaparoid/Fondaparinux
n=3 Participants
Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
|
Total
n=195 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Sex/Gender, Customized
Female
|
10 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
84 Participants
n=42 Participants
|
|
Sex/Gender, Customized
Male
|
22 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
110 Participants
n=42 Participants
|
|
Age, Continuous
|
66.4 Years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
61.8 Years
STANDARD_DEVIATION 13.7 • n=7 Participants
|
67.8 Years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
71.7 Years
STANDARD_DEVIATION 11.4 • n=4 Participants
|
71.5 Years
STANDARD_DEVIATION 12.1 • n=21 Participants
|
60.0 Years
STANDARD_DEVIATION 14.0 • n=8 Participants
|
71.0 Years
STANDARD_DEVIATION 8.6 • n=8 Participants
|
55.3 Years
STANDARD_DEVIATION 16.0 • n=24 Participants
|
56.0 Years
STANDARD_DEVIATION 0.0 • n=42 Participants
|
63.7 Years
STANDARD_DEVIATION 7.5 • n=42 Participants
|
68.5 Years
STANDARD_DEVIATION 12.5 • n=42 Participants
|
|
Number of participants receiving the indicated heparin treatment prior to HIT II
Only unfractionated heparin (UFH)
|
19 participants
n=5 Participants
|
1 participants
n=7 Participants
|
24 participants
n=5 Participants
|
53 participants
n=4 Participants
|
3 participants
n=21 Participants
|
7 participants
n=8 Participants
|
1 participants
n=8 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
1 participants
n=42 Participants
|
109 participants
n=42 Participants
|
|
Number of participants receiving the indicated heparin treatment prior to HIT II
Only low molecular weight heparin (LMWH)
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
10 participants
n=5 Participants
|
3 participants
n=4 Participants
|
1 participants
n=21 Participants
|
0 participants
n=8 Participants
|
3 participants
n=8 Participants
|
2 participants
n=24 Participants
|
1 participants
n=42 Participants
|
1 participants
n=42 Participants
|
24 participants
n=42 Participants
|
|
Number of participants receiving the indicated heparin treatment prior to HIT II
UFH and LMWH
|
11 participants
n=5 Participants
|
2 participants
n=7 Participants
|
12 participants
n=5 Participants
|
22 participants
n=4 Participants
|
7 participants
n=21 Participants
|
4 participants
n=8 Participants
|
1 participants
n=8 Participants
|
2 participants
n=24 Participants
|
0 participants
n=42 Participants
|
1 participants
n=42 Participants
|
62 participants
n=42 Participants
|
|
Number of participants receiving the indicated AT before HIT II with regard to rationale
Prophylactic
|
24 participants
n=5 Participants
|
2 participants
n=7 Participants
|
39 participants
n=5 Participants
|
66 participants
n=4 Participants
|
9 participants
n=21 Participants
|
8 participants
n=8 Participants
|
2 participants
n=8 Participants
|
3 participants
n=24 Participants
|
0 participants
n=42 Participants
|
2 participants
n=42 Participants
|
155 participants
n=42 Participants
|
|
Number of participants receiving the indicated AT before HIT II with regard to rationale
Therapeutic
|
14 participants
n=5 Participants
|
2 participants
n=7 Participants
|
18 participants
n=5 Participants
|
21 participants
n=4 Participants
|
6 participants
n=21 Participants
|
6 participants
n=8 Participants
|
3 participants
n=8 Participants
|
2 participants
n=24 Participants
|
1 participants
n=42 Participants
|
3 participants
n=42 Participants
|
76 participants
n=42 Participants
|
|
Number of participants receving the indicated AT before HIT II (specified) with regard to rationale
Prophylaxis (no further specification)
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
1 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
5 participants
n=42 Participants
|
|
Number of participants receving the indicated AT before HIT II (specified) with regard to rationale
Prophylaxis: Surgery
|
12 participants
n=5 Participants
|
2 participants
n=7 Participants
|
11 participants
n=5 Participants
|
62 participants
n=4 Participants
|
6 participants
n=21 Participants
|
5 participants
n=8 Participants
|
1 participants
n=8 Participants
|
3 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
102 participants
n=42 Participants
|
|
Number of participants receving the indicated AT before HIT II (specified) with regard to rationale
Prophylaxis: Internal Medicine
|
13 participants
n=5 Participants
|
0 participants
n=7 Participants
|
27 participants
n=5 Participants
|
4 participants
n=4 Participants
|
2 participants
n=21 Participants
|
5 participants
n=8 Participants
|
1 participants
n=8 Participants
|
1 participants
n=24 Participants
|
0 participants
n=42 Participants
|
2 participants
n=42 Participants
|
55 participants
n=42 Participants
|
|
Number of participants receving the indicated AT before HIT II (specified) with regard to rationale
Prophylaxis: Neurology/Neurosurgery
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
10 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
0 participants
n=8 Participants
|
1 participants
n=8 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
14 participants
n=42 Participants
|
|
Number of participants receving the indicated AT before HIT II (specified) with regard to rationale
Indication for thromboembolic therapy
|
14 participants
n=5 Participants
|
2 participants
n=7 Participants
|
18 participants
n=5 Participants
|
21 participants
n=4 Participants
|
6 participants
n=21 Participants
|
6 participants
n=8 Participants
|
3 participants
n=8 Participants
|
2 participants
n=24 Participants
|
1 participants
n=42 Participants
|
3 participants
n=42 Participants
|
76 participants
n=42 Participants
|
|
Number of participants with the indicated thromboembolic therapy (specified)
Deep vein thrombosis
|
5 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
2 participants
n=21 Participants
|
2 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
1 participants
n=42 Participants
|
14 participants
n=42 Participants
|
|
Number of participants with the indicated thromboembolic therapy (specified)
Pulmonary embolism
|
4 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
3 participants
n=21 Participants
|
1 participants
n=8 Participants
|
0 participants
n=8 Participants
|
1 participants
n=24 Participants
|
0 participants
n=42 Participants
|
1 participants
n=42 Participants
|
12 participants
n=42 Participants
|
|
Number of participants with the indicated thromboembolic therapy (specified)
Peripheral artery occlusive disease
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
1 participants
n=8 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
3 participants
n=42 Participants
|
|
Number of participants with the indicated thromboembolic therapy (specified)
Acute coronary syndrome
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
4 participants
n=4 Participants
|
0 participants
n=21 Participants
|
2 participants
n=8 Participants
|
0 participants
n=8 Participants
|
1 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
12 participants
n=42 Participants
|
|
Number of participants with the indicated thromboembolic therapy (specified)
Alternative anticoagulation in atrial fibrillation
|
4 participants
n=5 Participants
|
0 participants
n=7 Participants
|
9 participants
n=5 Participants
|
13 participants
n=4 Participants
|
1 participants
n=21 Participants
|
0 participants
n=8 Participants
|
2 participants
n=8 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
2 participants
n=42 Participants
|
31 participants
n=42 Participants
|
|
Number of participants with the indicated thromboembolic therapy (specified)
Alternative anticoagulation in cardiac valve
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
4 participants
n=42 Participants
|
|
Number of participants with the indicated thromboembolic therapy (specified)
Other
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
4 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
1 participants
n=42 Participants
|
0 participants
n=42 Participants
|
14 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: 19 January 2005 to 25 October 2009Population: 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.
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).
Outcome measures
| Measure |
Argatroban
n=32 Participants
Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
|
Lepirudin
n=4 Participants
Participants treated with lepirudin after HIT II
|
Danaparoid
n=46 Participants
Participants treated with danaparoid after HIT II
|
Fondaparinux
n=78 Participants
Participants treated with fondaparinux after HIT II
|
Argatroban/Fondaparinux
n=11 Participants
Participants treated with argatroban and fondaparinux after HIT II
|
Danaparoid/Argatroban
n=11 Participants
Participants treated with danaparoid and argatroban after HIT II
|
Danaparoid/Fondaparinux
n=5 Participants
Participants treated with danaparoid and fondaparinux after HIT II
|
Danaparoid/Lepirudin
n=4 Participants
Participants treated with danaparoid and lepirudin after HIT II
|
Danaparoid/Fondaparinux/Lepirudin
n=1 Participants
Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
|
Argatroban/Danaparoid/Fondaparinux
n=3 Participants
Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II
Thrombosis
|
31 participants
|
4 participants
|
45 participants
|
78 participants
|
11 participants
|
6 participants
|
5 participants
|
1 participants
|
1 participants
|
3 participants
|
|
Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II
Thrombosis and pulmonary embolism
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II
No thrombosis or pulmonary embolism
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
4 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
|
Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II
Pulmonary embolism
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II
Unknown
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 19 January 2005 to 25 October 2009Population: 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.
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.
Outcome measures
| Measure |
Argatroban
n=32 Participants
Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
|
Lepirudin
n=4 Participants
Participants treated with lepirudin after HIT II
|
Danaparoid
n=46 Participants
Participants treated with danaparoid after HIT II
|
Fondaparinux
n=78 Participants
Participants treated with fondaparinux after HIT II
|
Argatroban/Fondaparinux
n=11 Participants
Participants treated with argatroban and fondaparinux after HIT II
|
Danaparoid/Argatroban
n=11 Participants
Participants treated with danaparoid and argatroban after HIT II
|
Danaparoid/Fondaparinux
n=5 Participants
Participants treated with danaparoid and fondaparinux after HIT II
|
Danaparoid/Lepirudin
n=4 Participants
Participants treated with danaparoid and lepirudin after HIT II
|
Danaparoid/Fondaparinux/Lepirudin
n=1 Participants
Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
|
Argatroban/Danaparoid/Fondaparinux
n=3 Participants
Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Diagnosed With Bleeding After the Occurrence of HIT II
No Bleeding
|
30 participants
|
4 participants
|
43 participants
|
74 participants
|
11 participants
|
8 participants
|
5 participants
|
2 participants
|
1 participants
|
3 participants
|
|
Number of Participants Diagnosed With Bleeding After the Occurrence of HIT II
Bleeding
|
2 participants
|
0 participants
|
3 participants
|
4 participants
|
0 participants
|
3 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 19 January 2005 to 25 October 2009Population: 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.
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.
Outcome measures
| Measure |
Argatroban
n=32 Participants
Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
|
Lepirudin
n=4 Participants
Participants treated with lepirudin after HIT II
|
Danaparoid
n=46 Participants
Participants treated with danaparoid after HIT II
|
Fondaparinux
n=78 Participants
Participants treated with fondaparinux after HIT II
|
Argatroban/Fondaparinux
n=11 Participants
Participants treated with argatroban and fondaparinux after HIT II
|
Danaparoid/Argatroban
n=11 Participants
Participants treated with danaparoid and argatroban after HIT II
|
Danaparoid/Fondaparinux
n=5 Participants
Participants treated with danaparoid and fondaparinux after HIT II
|
Danaparoid/Lepirudin
n=4 Participants
Participants treated with danaparoid and lepirudin after HIT II
|
Danaparoid/Fondaparinux/Lepirudin
n=1 Participants
Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
|
Argatroban/Danaparoid/Fondaparinux
n=3 Participants
Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Fatal Complications After the Occurrence of HIT II
No fatal complication
|
27 participants
|
4 participants
|
35 participants
|
78 participants
|
11 participants
|
9 participants
|
5 participants
|
2 participants
|
1 participants
|
3 participants
|
|
Number of Participants With Fatal Complications After the Occurrence of HIT II
Fatal complication
|
5 participants
|
0 participants
|
11 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 19 January 2005 to 25 October 2009Population: 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.
Participants' medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs).
Outcome measures
| Measure |
Argatroban
n=32 Participants
Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
|
Lepirudin
n=4 Participants
Participants treated with lepirudin after HIT II
|
Danaparoid
n=46 Participants
Participants treated with danaparoid after HIT II
|
Fondaparinux
n=78 Participants
Participants treated with fondaparinux after HIT II
|
Argatroban/Fondaparinux
n=11 Participants
Participants treated with argatroban and fondaparinux after HIT II
|
Danaparoid/Argatroban
n=11 Participants
Participants treated with danaparoid and argatroban after HIT II
|
Danaparoid/Fondaparinux
n=5 Participants
Participants treated with danaparoid and fondaparinux after HIT II
|
Danaparoid/Lepirudin
n=4 Participants
Participants treated with danaparoid and lepirudin after HIT II
|
Danaparoid/Fondaparinux/Lepirudin
n=1 Participants
Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
|
Argatroban/Danaparoid/Fondaparinux
n=3 Participants
Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Underwent Amputation After the Occurrence of HIT II
Amputation
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants Who Underwent Amputation After the Occurrence of HIT II
No amputation
|
32 participants
|
4 participants
|
46 participants
|
78 participants
|
11 participants
|
10 participants
|
5 participants
|
3 participants
|
1 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 19 January 2005 to 25 October 2009Population: 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.
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.
Outcome measures
| Measure |
Argatroban
n=32 Participants
Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
|
Lepirudin
n=4 Participants
Participants treated with lepirudin after HIT II
|
Danaparoid
n=46 Participants
Participants treated with danaparoid after HIT II
|
Fondaparinux
n=78 Participants
Participants treated with fondaparinux after HIT II
|
Argatroban/Fondaparinux
n=11 Participants
Participants treated with argatroban and fondaparinux after HIT II
|
Danaparoid/Argatroban
n=11 Participants
Participants treated with danaparoid and argatroban after HIT II
|
Danaparoid/Fondaparinux
n=5 Participants
Participants treated with danaparoid and fondaparinux after HIT II
|
Danaparoid/Lepirudin
n=4 Participants
Participants treated with danaparoid and lepirudin after HIT II
|
Danaparoid/Fondaparinux/Lepirudin
n=3 Participants
Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
|
Argatroban/Danaparoid/Fondaparinux
n=1 Participants
Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II
Recurrent thrombocytopenia
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
3 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II
Persistent thrombocytopenia
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II
No thrombocytopenia
|
31 participants
|
4 participants
|
44 participants
|
78 participants
|
11 participants
|
8 participants
|
5 participants
|
3 participants
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 19 January 2005 to 25 October 2009Population: 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.
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.
Outcome measures
| Measure |
Argatroban
n=32 Participants
Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
|
Lepirudin
n=4 Participants
Participants treated with lepirudin after HIT II
|
Danaparoid
n=46 Participants
Participants treated with danaparoid after HIT II
|
Fondaparinux
n=78 Participants
Participants treated with fondaparinux after HIT II
|
Argatroban/Fondaparinux
n=11 Participants
Participants treated with argatroban and fondaparinux after HIT II
|
Danaparoid/Argatroban
n=11 Participants
Participants treated with danaparoid and argatroban after HIT II
|
Danaparoid/Fondaparinux
n=5 Participants
Participants treated with danaparoid and fondaparinux after HIT II
|
Danaparoid/Lepirudin
n=4 Participants
Participants treated with danaparoid and lepirudin after HIT II
|
Danaparoid/Fondaparinux/Lepirudin
n=1 Participants
Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
|
Argatroban/Danaparoid/Fondaparinux
n=3 Participants
Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced Skin Changes (Erythema and Necrosis) After the Occurrence of HIT II
No skin changes
|
32 participants
|
4 participants
|
45 participants
|
78 participants
|
11 participants
|
11 participants
|
5 participants
|
3 participants
|
0 participants
|
3 participants
|
|
Number of Participants Who Experienced Skin Changes (Erythema and Necrosis) After the Occurrence of HIT II
Skin changes
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
Adverse Events
Argatroban
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lepirudin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Danaparoid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fondaparinux
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Argatroban/Fondaparinux
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Danaparoid/Argatroban
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Danaparoid/Fondaparinux
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Danaparoid/Lepirudin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Danaparoid/Fondaparinux/Lepirudin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Argatroban/Danaparoid/Fondaparinux
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Cente
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER