Retrospective Registry of Patients With Acute Heparin-induced Thrombocytopenia Type II
Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT01304238
Collaborator
(none)
195
11
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Study Type:
Observational
Actual Enrollment
:
195 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Systematische Dokumentation Von Patienten Mit Akutem HIT-Verdacht
Study Start Date
:
Feb 1, 2009
Actual Primary Completion Date
:
Jan 1, 2010
Actual Study Completion Date
:
Jan 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| lepirudin lepirudin treated subjects |
Drug: lepirudin
lepirudin
|
| danaparoid danaparoid treated subjects |
Drug: danaparoid
danaparoid
|
| argatroban argatroban treated subjects |
Drug: argatroban
argatroban
|
| fondaparinux fondaparinux treated subjects |
Drug: fondaparinux
fondaparinux
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts 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:
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01304238
Other Study ID Numbers:
- 108745
First Posted:
Feb 25, 2011
Last Update Posted:
Jul 6, 2017
Last Verified:
Jun 1, 2017
Keywords provided by GlaxoSmithKline
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Argatroban | Lepirudin | Danaparoid | Fondaparinux | Argatroban/Fondaparinux | Danaparoid/Argatroban | Danaparoid/Fondaparinux | Danaparoid/Lepirudin | Danaparoid/Fondaparinux/Lepirudin | Argatroban/Danaparoid/Fondaparinux |
|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
Baseline Characteristics
| Arm/Group Title | Argatroban | Lepirudin | Danaparoid | Fondaparinux | Argatroban/Fondaparinux | Danaparoid/Argatroban | Danaparoid/Fondaparinux | Danaparoid/Lepirudin | Danaparoid/Fondaparinux/Lepirudin | Argatroban/Danaparoid/Fondaparinux | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 Participants | 32 | 4 | 46 | 78 | 11 | 11 | 5 | 4 | 1 | 3 | 195 |
| Age (Years) [Mean (Standard Deviation) ] | |||||||||||
| Mean (Standard Deviation) [Years] |
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 (Number) [Number] | |||||||||||
| Female |
10
31.3%
|
1
25%
|
21
45.7%
|
35
44.9%
|
5
45.5%
|
5
45.5%
|
2
40%
|
2
50%
|
1
100%
|
2
66.7%
|
84
43.1%
|
| Male |
22
68.8%
|
2
50%
|
25
54.3%
|
43
55.1%
|
6
54.5%
|
6
54.5%
|
3
60%
|
2
50%
|
0
0%
|
1
33.3%
|
110
56.4%
|
| Number of participants receiving the indicated heparin treatment prior to HIT II (participants) [Number] | |||||||||||
| Only unfractionated heparin (UFH) |
19
59.4%
|
1
25%
|
24
52.2%
|
53
67.9%
|
3
27.3%
|
7
63.6%
|
1
20%
|
0
0%
|
0
0%
|
1
33.3%
|
109
55.9%
|
| Only low molecular weight heparin (LMWH) |
2
6.3%
|
1
25%
|
10
21.7%
|
3
3.8%
|
1
9.1%
|
0
0%
|
3
60%
|
2
50%
|
1
100%
|
1
33.3%
|
24
12.3%
|
| UFH and LMWH |
11
34.4%
|
2
50%
|
12
26.1%
|
22
28.2%
|
7
63.6%
|
4
36.4%
|
1
20%
|
2
50%
|
0
0%
|
1
33.3%
|
62
31.8%
|
| Number of participants receiving the indicated AT before HIT II with regard to rationale (participants) [Number] | |||||||||||
| Prophylactic |
24
75%
|
2
50%
|
39
84.8%
|
66
84.6%
|
9
81.8%
|
8
72.7%
|
2
40%
|
3
75%
|
0
0%
|
2
66.7%
|
155
79.5%
|
| Therapeutic |
14
43.8%
|
2
50%
|
18
39.1%
|
21
26.9%
|
6
54.5%
|
6
54.5%
|
3
60%
|
2
50%
|
1
100%
|
3
100%
|
76
39%
|
| Number of participants receving the indicated AT before HIT II (specified) with regard to rationale (participants) [Number] | |||||||||||
| Prophylaxis (no further specification) |
2
6.3%
|
0
0%
|
0
0%
|
1
1.3%
|
1
9.1%
|
1
9.1%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
5
2.6%
|
| Prophylaxis: Surgery |
12
37.5%
|
2
50%
|
11
23.9%
|
62
79.5%
|
6
54.5%
|
5
45.5%
|
1
20%
|
3
75%
|
0
0%
|
0
0%
|
102
52.3%
|
| Prophylaxis: Internal Medicine |
13
40.6%
|
0
0%
|
27
58.7%
|
4
5.1%
|
2
18.2%
|
5
45.5%
|
1
20%
|
1
25%
|
0
0%
|
2
66.7%
|
55
28.2%
|
| Prophylaxis: Neurology/Neurosurgery |
2
6.3%
|
0
0%
|
10
21.7%
|
0
0%
|
1
9.1%
|
0
0%
|
1
20%
|
0
0%
|
0
0%
|
0
0%
|
14
7.2%
|
| Indication for thromboembolic therapy |
14
43.8%
|
2
50%
|
18
39.1%
|
21
26.9%
|
6
54.5%
|
6
54.5%
|
3
60%
|
2
50%
|
1
100%
|
3
100%
|
76
39%
|
| Number of participants with the indicated thromboembolic therapy (specified) (participants) [Number] | |||||||||||
| Deep vein thrombosis |
5
15.6%
|
0
0%
|
2
4.3%
|
2
2.6%
|
2
18.2%
|
2
18.2%
|
0
0%
|
0
0%
|
0
0%
|
1
33.3%
|
14
7.2%
|
| Pulmonary embolism |
4
12.5%
|
0
0%
|
1
2.2%
|
1
1.3%
|
3
27.3%
|
1
9.1%
|
0
0%
|
1
25%
|
0
0%
|
1
33.3%
|
12
6.2%
|
| Peripheral artery occlusive disease |
0
0%
|
0
0%
|
1
2.2%
|
1
1.3%
|
0
0%
|
0
0%
|
1
20%
|
0
0%
|
0
0%
|
0
0%
|
3
1.5%
|
| Acute coronary syndrome |
1
3.1%
|
1
25%
|
3
6.5%
|
4
5.1%
|
0
0%
|
2
18.2%
|
0
0%
|
1
25%
|
0
0%
|
0
0%
|
12
6.2%
|
| Alternative anticoagulation in atrial fibrillation |
4
12.5%
|
0
0%
|
9
19.6%
|
13
16.7%
|
1
9.1%
|
0
0%
|
2
40%
|
0
0%
|
0
0%
|
2
66.7%
|
31
15.9%
|
| Alternative anticoagulation in cardiac valve |
1
3.1%
|
0
0%
|
0
0%
|
3
3.8%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
4
2.1%
|
| Other |
3
9.4%
|
1
25%
|
3
6.5%
|
0
0%
|
2
18.2%
|
4
36.4%
|
0
0%
|
0
0%
|
1
100%
|
0
0%
|
14
7.2%
|
Outcome Measures
| Title | Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
| Measure Participants | 32 | 4 | 46 | 78 | 11 | 11 | 5 | 4 | 1 | 3 |
| Thrombosis |
31
96.9%
|
4
100%
|
45
97.8%
|
78
100%
|
11
100%
|
6
54.5%
|
5
100%
|
1
25%
|
1
100%
|
3
100%
|
| No thrombosis or pulmonary embolism |
1
3.1%
|
0
0%
|
1
2.2%
|
0
0%
|
0
0%
|
4
36.4%
|
0
0%
|
2
50%
|
0
0%
|
0
0%
|
| Pulmonary embolism |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
9.1%
|
0
0%
|
1
25%
|
0
0%
|
0
0%
|
| Thrombosis and pulmonary embolism |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Number of Participants Diagnosed With Bleeding After the Occurrence of HIT II |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
| Measure Participants | 32 | 4 | 46 | 78 | 11 | 11 | 5 | 4 | 1 | 3 |
| No Bleeding |
30
93.8%
|
4
100%
|
43
93.5%
|
74
94.9%
|
11
100%
|
8
72.7%
|
5
100%
|
2
50%
|
1
100%
|
3
100%
|
| Bleeding |
2
6.3%
|
0
0%
|
3
6.5%
|
4
5.1%
|
0
0%
|
3
27.3%
|
0
0%
|
2
50%
|
0
0%
|
0
0%
|
| Title | Number of Participants With Fatal Complications After the Occurrence of HIT II |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
| Measure Participants | 32 | 4 | 46 | 78 | 11 | 11 | 5 | 4 | 1 | 3 |
| No fatal complication |
27
84.4%
|
4
100%
|
35
76.1%
|
78
100%
|
11
100%
|
9
81.8%
|
5
100%
|
2
50%
|
1
100%
|
3
100%
|
| Fatal complication |
5
15.6%
|
0
0%
|
11
23.9%
|
0
0%
|
0
0%
|
2
18.2%
|
0
0%
|
2
50%
|
0
0%
|
0
0%
|
| Title | Number of Participants Who Underwent Amputation After the Occurrence of HIT II |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
| Measure Participants | 32 | 4 | 46 | 78 | 11 | 11 | 5 | 4 | 1 | 3 |
| No amputation |
32
100%
|
4
100%
|
46
100%
|
78
100%
|
11
100%
|
10
90.9%
|
5
100%
|
3
75%
|
1
100%
|
3
100%
|
| Amputation |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
9.1%
|
0
0%
|
1
25%
|
0
0%
|
0
0%
|
| Title | Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
| Measure Participants | 32 | 4 | 46 | 78 | 11 | 11 | 5 | 4 | 3 | 1 |
| Recurrent thrombocytopenia |
0
0%
|
0
0%
|
1
2.2%
|
0
0%
|
0
0%
|
3
27.3%
|
0
0%
|
1
25%
|
0
0%
|
0
0%
|
| Persistent thrombocytopenia |
1
3.1%
|
0
0%
|
1
2.2%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
2
66.7%
|
| No thrombocytopenia |
31
96.9%
|
4
100%
|
44
95.7%
|
78
100%
|
11
100%
|
8
72.7%
|
5
100%
|
3
75%
|
1
100%
|
1
33.3%
|
| Title | Number of Participants Who Experienced Skin Changes (Erythema and Necrosis) After the Occurrence of HIT II |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
| Measure Participants | 32 | 4 | 46 | 78 | 11 | 11 | 5 | 4 | 1 | 3 |
| No skin changes |
32
100%
|
4
100%
|
45
97.8%
|
78
100%
|
11
100%
|
11
100%
|
5
100%
|
3
75%
|
0
0%
|
3
100%
|
| Skin changes |
0
0%
|
0
0%
|
1
2.2%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
25%
|
1
100%
|
0
0%
|
Adverse Events
| Time Frame | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | ||||||||||
| 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 (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||||||
Serious Adverse Events |
||||||||||||||||||||
| Argatroban | Lepirudin | Danaparoid | Fondaparinux | Argatroban/Fondaparinux | Danaparoid/Argatroban | Danaparoid/Fondaparinux | Danaparoid/Lepirudin | Danaparoid/Fondaparinux/Lepirudin | Argatroban/Danaparoid/Fondaparinux | |||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||||||
| Argatroban | Lepirudin | Danaparoid | Fondaparinux | Argatroban/Fondaparinux | Danaparoid/Argatroban | Danaparoid/Fondaparinux | Danaparoid/Lepirudin | Danaparoid/Fondaparinux/Lepirudin | Argatroban/Danaparoid/Fondaparinux | |||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||||||||
Limitations/Caveats
Due to the retrospective nature of the data collection in this study, it is impossible to be precise about dose and frequency of dosing.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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
Other Study ID Numbers:
- 108745
First Posted:
Feb 25, 2011
Last Update Posted:
Jul 6, 2017
Last Verified:
Jun 1, 2017