Palonosetron and Blood Coagulation

Seoul National University

Status: Enrolling

Conditions: Blood Coagulation Disorder

Treatments: Drug: 0 ul of palonosetron; Drug: 100 ul of palonosetron; Drug: 10 ul of palonosetron; Drug: 1 ul of palonosetron

Study type: Interventional

Funder types: Other

Identifiers

NCT04507711

B-2002/631-304

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Hematologic disease
• Anticoagulant medication

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 4 patient groups

0 ng/ml

Experimental group

Description:

Blood specimen which was added of 0 ul of palonosetron

Treatment:

Drug: 0 ul of palonosetron

25 ng/ml

Experimental group

Description:

Blood specimen which was added of 1 ul of palonosetron

Treatment:

Drug: 1 ul of palonosetron

250 ng/ml

Experimental group

Description:

Blood specimen which was added of 10 ul of palonosetron

Treatment:

Drug: 10 ul of palonosetron

2500 ng/ml

Experimental group

Description:

Blood specimen which was added of 100 ul of palonosetron

Treatment:

Drug: 100 ul of palonosetron