NCT04507711

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 11, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

September 16, 2020

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

March 15, 2023

Status Verified

March 1, 2023

Enrollment Period

3.2 years

First QC Date

July 31, 2020

Last Update Submit

March 13, 2023

Conditions

Blood Coagulation Disorder

Outcome Measures

Primary Outcomes (1)

  • Citrated Functional Fibrinogen

    Provides clot strength based on fibrinogen contribution

    During the thromboelastography analysis/ an average of 1 hour

Secondary Outcomes (7)

  • Citrated Kaolin

    During the thromboelastography analysis/ an average of 1 hour

  • Citrated Kaolin Heparinase

    During the thromboelastography analysis/ an average of 1 hour

  • Citrated Rapid Thromboelastography

    During the thromboelastography analysis/ an average of 1 hour

  • Heparinized Kaloin Heprinase

    During the thromboelastography analysis/ an average of 1 hour

  • Activator F

    During the thromboelastography analysis/ an average of 1 hour

  • +2 more secondary outcomes

Study Arms (4)

0 ng/ml

EXPERIMENTAL

Blood specimen which was added of 0 ul of palonosetron

Drug: 0 ul of palonosetron

25 ng/ml

EXPERIMENTAL

Blood specimen which was added of 1 ul of palonosetron

Drug: 1 ul of palonosetron

250 ng/ml

EXPERIMENTAL

Blood specimen which was added of 10 ul of palonosetron

Drug: 10 ul of palonosetron

2500 ng/ml

EXPERIMENTAL

Blood specimen which was added of 100 ul of palonosetron

Drug: 100 ul of palonosetron

Interventions

0 ul of palonosetronDRUG

Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (0 ul) using palonosetron

0 ng/ml
1 ul of palonosetronDRUG

Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (1 ul) using palonosetron

25 ng/ml
10 ul of palonosetronDRUG

Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (10 ul) using palonosetron

250 ng/ml
100 ul of palonosetronDRUG

Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (100 ul) using palonosetron

2500 ng/ml

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Hematologic disease
  • Anticoagulant medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National Univ. Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

RECRUITING

MeSH Terms

Conditions

Blood Coagulation Disorders

Interventions

Palonosetron

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

QuinuclidinesHeterocyclic Compounds, Bridged-RingHeterocyclic CompoundsIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Hyo-Seok Na, MD., PhD.

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyo-Seok Na, MD., PhD.

CONTACT

82317877507hsknana@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 31, 2020

First Posted

August 11, 2020

Study Start

September 16, 2020

Primary Completion

November 15, 2023

Study Completion

December 15, 2023

Last Updated

March 15, 2023

Record last verified: 2023-03

Locations

KR(1)