A multicenter, single-arm, open-label, phase III clinical study to investigate the efficacy and safety of GB-0706 in patients developing heparin resistance during cardiovascular surgery using a cardiopulmonary bypass
Active, not recruiting
- Conditions
- Patients developing heparin resistance during cardiovascular surgery using a cardiopulmonary bypass
- Registration Number
- jRCT2031230269
- Lead Sponsor
- Japan Blood Products Organization
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
- 18 years old or older and 85 years or younger at the time when informed consent is obtained
- Receiving elective cardiovascular surgery using a cardiopulmonary bypass
- Platelet count of 178,000 / microliter or more at laboratory tests at screening
- Fibrinogen count of 264 mg/dL or more at laboratory tests at screening
- Meeting all the inclusion criteria 1 to 4 and found to have Heparin Resistance according to the definition of Heparin Resistance specified in this study
Exclusion Criteria
- Having been administered a specified prohibited concomitant drug or prohibited concomitant therapy before administration of the study drug
- Having congenital antithrombin III deficiency
- Having a history of heparin-induced thrombocytopenia
- Having a history of antiphospholipid syndrome
- Receiving surgery other than cardiovascular surgery at the same time
- Found to have a history of coagulation disorder (such as von Willebrand disease) for reasons such as a medical history of hemorrhagic disease or test history
- Having congenital or acquired coagulation factor deficiency or abnormality
Study & Design
- Study Type
- Interventional
- Study Design
- single assignment
- Primary Outcome Measures
Name Time Method ACT 480 seconds or over The percentage of subjects with ACT 480 seconds or over (improved Heparin resistance) after administration of the study drug (study drug dose (1), or, if the study drug is administered twice, study drug dose (2))
- Secondary Outcome Measures
Name Time Method The change in ACT from the additional dose of heparin to after administration of the study drug after administration of the study drug The change in ACT from the additional dose of heparin to after administration of the study drug (study drug dose (1), or, if the study drug is administered twice, study drug dose (2))