Palonosetron and Blood Coagulation

Blood Coagulation Disorder Clinical Trial

Official title:

The Effect of a Palonosetron on Blood Coagulation: In Vitro, Volunteer Study Using Thromboelastography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04507711
• Other study ID #: B-2002/631-304
• Status: Recruiting
• Phase: N/A
• Start date: September 16, 2020
• Est. completion date: December 15, 2023

Study information

• Verified date: March 2023
• Source: Seoul National University Bundang Hospital
• Contact: Hyo-Seok Na, MD., PhD.
• Phone: 82317877507
• Email: hsknana[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 15, 2023
• Est. primary completion date: November 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy volunteers
• Age: 20 to 65 years
• Body weight > 50 kg
• Volunteers who provided informed consent

Exclusion Criteria:

• Hematologic disease
• Anticoagulant medication

Related Conditions & MeSH terms

• Blood Coagulation Disorder
• Blood Coagulation Disorders
• Hemostatic Disorders

Intervention

Drug:
• 0 ul of palonosetron
Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (0 ul) using palonosetron
• 1 ul of palonosetron
Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (1 ul) using palonosetron
• 10 ul of palonosetron
Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (10 ul) using palonosetron
• 100 ul of palonosetron
Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (100 ul) using palonosetron

Locations

Country	Name	City	State
Korea, Republic of	Seoul National Univ. Bundang Hospital	Seongnam	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Citrated Functional Fibrinogen	Provides clot strength based on fibrinogen contribution	During the thromboelastography analysis/ an average of 1 hour
Secondary	Citrated Kaolin	Normal thromboelastography	During the thromboelastography analysis/ an average of 1 hour
Secondary	Citrated Kaolin Heparinase	To assess the effect of heparin	During the thromboelastography analysis/ an average of 1 hour
Secondary	Citrated Rapid Thromboelastography	A quicker assessment of clot strength, without assessment of clot initiation	During the thromboelastography analysis/ an average of 1 hour
Secondary	Heparinized Kaloin Heprinase	To measure the platelet function	During the thromboelastography analysis/ an average of 1 hour
Secondary	Activator F	To elimitate the platelt function	During the thromboelastography analysis/ an average of 1 hour
Secondary	Adenosine diphosphate	To measure the drug effect	During the thromboelastography analysis/ an average of 1 hour
Secondary	Arachidonic acid	To measure the drug effect	During the thromboelastography analysis/ an average of 1 hour