This study is currently not recruiting participants.

A Multicenter Study to Demonstrate the Substantial Equivalence of Sekisui Coagulation System Assays to International Laboratories? (IL) Coagulation Systems Assays

Investigation of a Laboratory Test for Clotting Disorders

Not Recruiting
18 years - 100 years
All
Phase N/A
1 Location

Brief description of study.

The purpose of this study is to determine if this new laboratory test performs as well as the already existing laboratory test that is used in the lab to detect clotting disorders and or bleeding abnormalities.

Detailed description of study

The purpose of this study is to establish reference range values and demonstrate that the performance of coagulation assays tested on the Sekisui Coagulation System are substantially equivalent to similar Instrumentation Laboratory (IL) assays tested on the IL ACT TOP System (the standard of care assay).

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: healthy
  • Age: 18 years - 100 years
  • Gender: All

This study investigates a laboratory test used to find clotting disorders and bleeding problems. Clotting disorders affect how blood clots, which can lead to excessive bleeding or clotting. The purpose of this study is to see if the new test works as well as the current tests used in labs.

Participants will have their blood tested using both the new laboratory test and the standard test. This is to compare how well the new test performs against the standard test used in labs.

  • Who can participate: Eligible participants are adults aged 18 and older who have been diagnosed with or are suspected to have clotting disorders. Additional eligibility criteria may apply.
  • Study details: Participants will have their blood tested using both the investigational test and the standard test. This will help researchers compare the performance of the two tests.
Updated on 19 Feb 2024. Study ID: 1510449658

Interested in the study?

Select a study center that’s convenient for you, and get in touch with the study team.

Connect with the study team