Heparin-induced Thrombocytopenia Type II
Conditions
Keywords
Argatroban, heparin induced thrombocytopenia (HIT), direct thrombin inhibitor (DTI)
Brief summary
The purpose of this study is to collect data on the clinical management of Argatroban in patients with suspected or confirmed heparin-induced thrombocytopenia Type II, with or without ongoing thrombosis who require parenteral antithrombotic therapy
Interventions
DRUGargatroban
Sponsors
Tanabe Pharma Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects aged \>= 18 years * Females of child bearing potential must have a negative urine pregnancy test prior to entry into the study * Patients with suspected or confirmed heparin-induced thrombocytopenia Type II, with or without ongoing thrombosis who require parenteral anticoagulation * Signed written informed consent by the subject, or if the subject is unable to do so, consent will be sought from their family member, or a trusted person nominated by the subject or the legal representative
Exclusion criteria
* Uncontrolled bleeding * Severe hepatic impairment (Child-Pugh Class C) * Hypersensitivity to argatroban or to any of the excipients (sorbitol and ethanol) * Pregnancy (exclusion by routine urine test) * Lactating woman
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of All-cause Death, Thrombosis (New and Extended) and Unplanned Amputation | During and 30 days after argatroban treatment | — |
| All-cause Death | During and 30 days after argatroban treatment | — |
| Death Related to Heparin-induced Thrombocytopenia (HIT) | During and 30 days after argatroban treatment | — |
| Number of Patients With Thrombosis (New and Extended) | During and 30 days after argatroban treatment | — |
| Number of Patients With Unplanned Amputation | During and 30 days after argatroban treatment | — |
| Number of Patients With Major or Minor Bleeding | During and 30 days after argatroban treatment | Major bleeding is defined as i) overt and associated with a fall in the haemoglobin level 2 g/dl or more, ii) leads to transfusion of 2 units or more, iii) is retroperitoneal, iv) occurs into a major prosthetic joint, or v) in intracranial. Minor bleeding is defined as overt bleeding that does not meet the criteria of major bleeding. |
| Number of Patients With Platelet Count Recovery | Day 3 | Platelet increase of ≥ 100G/L or 50%. |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Argatroban start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 6 |
Baseline characteristics
| Characteristic | Argatroban |
|---|---|
| Age, Continuous | 71.7 years STANDARD_DEVIATION 10.4 |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 17 / 20 |
| serious Total, serious adverse events | 14 / 20 |
Outcome results
Primary
All-cause Death
Time frame: During and 30 days after argatroban treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Argatroban | All-cause Death | 6 participants |
Primary
Composite of All-cause Death, Thrombosis (New and Extended) and Unplanned Amputation
Time frame: During and 30 days after argatroban treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Argatroban | Composite of All-cause Death, Thrombosis (New and Extended) and Unplanned Amputation | 10 participants |
Primary
Death Related to Heparin-induced Thrombocytopenia (HIT)
Time frame: During and 30 days after argatroban treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Argatroban | Death Related to Heparin-induced Thrombocytopenia (HIT) | 0 participants |
Primary
Number of Patients With Major or Minor Bleeding
Major bleeding is defined as i) overt and associated with a fall in the haemoglobin level 2 g/dl or more, ii) leads to transfusion of 2 units or more, iii) is retroperitoneal, iv) occurs into a major prosthetic joint, or v) in intracranial. Minor bleeding is defined as overt bleeding that does not meet the criteria of major bleeding.
Time frame: During and 30 days after argatroban treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Argatroban | Number of Patients With Major or Minor Bleeding | 4 participants |
Primary
Number of Patients With Platelet Count Recovery
Platelet increase of ≥ 100G/L or 50%.
Time frame: Day 3
Population: Data are missing in 3 patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Argatroban | Number of Patients With Platelet Count Recovery | 12 participants |
Primary
Number of Patients With Thrombosis (New and Extended)
Time frame: During and 30 days after argatroban treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Argatroban | Number of Patients With Thrombosis (New and Extended) | 5 participants |
Primary
Number of Patients With Unplanned Amputation
Time frame: During and 30 days after argatroban treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Argatroban | Number of Patients With Unplanned Amputation | 0 participants |