Interference by Activated Protein C Resistance in the Determination of Protein S Activity (PS)

December 12, 2023 updated by: University Hospital, Strasbourg, France
Protein S is an anticoagulant protein and a cofactor of protein C. It is recommended to explore it first by a functional (chronometric) technique by assessing its cofactor activity of activated protein C. Existing tests measure the prolongation of a coagulation time. These tests are all dependent on factor V, but some patients have mutations in factor V (including V Leiden) that make them resistant to activated protein C activity. It is suspected that these mutations lead to underestimations of protein S activity by chronometric technique.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

9470

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Laboratoire d'Hématologie - CHU de Strasbourg - France
        • Contact:
        • Principal Investigator:
          • Agathe HERB, PharmD
        • Sub-Investigator:
          • Baptiste PANAGET, PharmD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Adult patients (≥ 18 years) for whom a sample has been sent to the HUS Hematology Laboratory for measurement of protein S activity between 28/12/2009 and 29/12/2020

Description

Inclusion criteria:

  • Patient of legal age (≥ 18 years)
  • Patient for whom a sample has been sent to the HUS Hematology Laboratory for measurement of protein S activity between 28/12/2009 and 29/12/2020
  • Patient who does not object to the reuse of his/her medical data for scientific research purposes.

Exclusion criteria:

  • Minor patient
  • Patient with incomplete data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Functional test protein C resistance
Time Frame: Through study completion, an average of 2 months
Through study completion, an average of 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

September 6, 2022

First Submitted That Met QC Criteria

December 12, 2023

First Posted (Actual)

December 27, 2023

Study Record Updates

Last Update Posted (Actual)

December 27, 2023

Last Update Submitted That Met QC Criteria

December 12, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8674

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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