Palonosetron and Blood Coagulation
Not Applicable
Recruiting
- Conditions
- Blood Coagulation Disorder
- Interventions
- Drug: 0 ul of palonosetronDrug: 1 ul of palonosetronDrug: 10 ul of palonosetronDrug: 100 ul of palonosetron
- Registration Number
- NCT04507711
- Lead Sponsor
- Seoul National University Bundang Hospital
- Brief Summary
Palonosetron may alter whole blood coagulation. However, little is known about the dose-response relationships according to the blood concentration of palonosetron. The investigators therefore will perform the present study to measure the effect of palonosetron levels using thromboelastography.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
- Healthy volunteers
- Age: 20 to 65 years
- Body weight > 50 kg
- Volunteers who provided informed consent
Exclusion Criteria
- Hematologic disease
- Anticoagulant medication
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 0 ng/ml 0 ul of palonosetron Blood specimen which was added of 0 ul of palonosetron 25 ng/ml 1 ul of palonosetron Blood specimen which was added of 1 ul of palonosetron 250 ng/ml 10 ul of palonosetron Blood specimen which was added of 10 ul of palonosetron 2500 ng/ml 100 ul of palonosetron Blood specimen which was added of 100 ul of palonosetron
- Primary Outcome Measures
Name Time Method Citrated Functional Fibrinogen During the thromboelastography analysis/ an average of 1 hour Provides clot strength based on fibrinogen contribution
- Secondary Outcome Measures
Name Time Method Citrated Kaolin During the thromboelastography analysis/ an average of 1 hour Normal thromboelastography
Citrated Kaolin Heparinase During the thromboelastography analysis/ an average of 1 hour To assess the effect of heparin
Citrated Rapid Thromboelastography During the thromboelastography analysis/ an average of 1 hour A quicker assessment of clot strength, without assessment of clot initiation
Heparinized Kaloin Heprinase During the thromboelastography analysis/ an average of 1 hour To measure the platelet function
Activator F During the thromboelastography analysis/ an average of 1 hour To elimitate the platelt function
Adenosine diphosphate During the thromboelastography analysis/ an average of 1 hour To measure the drug effect
Arachidonic acid During the thromboelastography analysis/ an average of 1 hour To measure the drug effect
Trial Locations
- Locations (1)
Seoul National Univ. Bundang Hospital
🇰🇷Seongnam, Gyeonggi, Korea, Republic of