Evaluation of the Effect of Dextran Sulphate on Anti-Xa Activities Measured (DEXHEP)

February 8, 2021 updated by: Rennes University Hospital

Evaluation of the Effect of Dextran Sulphate on Anti-Xa Activities Measured in Patients Treated With Unfractionated Heparin in Different Indications-DEXHEP

The measurement of anti-Xa activity is classically used for the dose adjustement of unfractionated heparin (UFH) treatment and to monitor reversal of UFH by protamine during cardiac surgery with cardiopulmonary bypass (CPB). Three categories of reagents are currently available in France for the measurement of anti-Xa activity: antithrombin-containing reagents (very little used), antithrombin-free reagents and antithrombin-free reagents with dextran sulphate. Significant differences in anti-Xa results based on the reagents used were described, particularly after protamine neutralization in CPB. Indeed, dextran sulphate, contained in some reagents, could dissociate the heparin/protamine complex contributing to the higher levels of anti-Xa with these reagents. The differences observed in these patients are likely related to the presence of platelet factor 4 (PF4) in the samples from either PF4 present in vivo in patients or released in vitro after blood collection. These differences may lead to different therapeutic attitudes, including the re-administration of protamine to neutralize heparin at the end of CBP

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Any hospitalized patient receiving UFH in the intensive, cardiac surgery and medicine departments of the participating centres will be offered the study by investigator. It will be included in the study after validation of the selection criteria and after collecting its non-opposition. This participation will not change the medical care of the participants.

Patients will be divided into four groups:

  • Group 1: patients with cardiac surgery with CBP. Blood samples in the operating room, 5 to 10 minutes after neutralization of heparin by protamine.
  • Group 2: patients who had cardiac surgery with CBP, between day 1 and day 5 after surgery.
  • Group 3: hospitalized patients in intensive care unit, including patients on extracorporeal life support (ECLS).

Group 4: patients hospitalized in a medical non-intensive care ward.

The response to heparin treatment varies considerably depending on the clinical situation. The results found in one indication are not transposable to another indication. The 4 patient groups will provide a comprehensive response to situations in which heparin is used.

For each patient, during the usual follow-up of anti-Xa activity, and only once per patient, 3 to 4 additional blood tubes - 1 citrate tube (0.109 M) of 5 mL or 2 citrate tubes of 3 mL and 2 tubes CTAD (Citrate-Theophylline, Adenosine, Dipyrioledam) of 3 mL - will be taken during a blood test carried out in common practice. Thus, no additional invasive gestures are added by this search. CTAD contains, in addition to citrate, a platelet activation inhibitor and thus limits the in-vitro activation of platelets and thus the release of PF4.

Blood samples will be handle according to the usual procedures of each centre. All plasma will be aliquoted and stored at -80oC, until the end of inclusions in the hematology laboratories of each center.

At the end of the inclusion period, the aliquotes will be sent to the hematology laboratories of the Necker University Hospital and the University Hospital of Rennes for centralized testing.

The measurement of anti-Xa activities will be carried out on frozen-defrosted citrate and CTAD plasma with with 4 reagents:

  • STA-Liquid anti-Xa (STAGO) (not containing dextran)
  • Biophen Heparin LRT (Hyphen) (containing dextran)
  • Berichrom (Siemens) with dextran
  • Berichrom (Siemens) without dextran

The dosage of platelet factor 4 and beta-TG will be performed on frozen-defrosted plasma with CTAD with asserachrom PF4 and Asserachrom beta-TG (Diagnostica Stago) kits.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
164

Contacts and Locations

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

Study Locations

  • France
      • Bordeaux, France, 33604
        • CHU Bordeaux
      • Dijon, France, 21033
        • CHU de Dijon
      • Le Chesnay, France, 78150
        • CH de Versailles
      • Lille, France, 59037
        • CHU de LILLE
      • Paris, France, 75010
        • APHP, CHU Lariboisière
      • Paris, France, 75743
        • APHP, HOPITAL Necker enfants malades
      • Rennes, France, 35000
        • Rennes University Hospital
      • Vandœuvre-lès-Nancy, France, 54500
        • CHU de NANCY

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Any hospitalized patient receiving UFH in the intensive, cardiac surgery and medicine departments

Description

Inclusion Criteria:

  • Patients over the age of 18;
  • Hospitalized patients to receive UFH;
  • No patient opposition.

Patients will be divided into four groups:

  • Group 1: patients with cardiac surgery with CBP. Blood samples in the operating room, 5 to 10 minutes after neutralization of heparin by protamine.
  • Group 2: patients who had cardiac surgery with CBP, between day 1 and day 5 after surgery.
  • Group 3: hospitalized patients in intensive care unit, including patients on extracorporeal life support (ECLS).

Group 4: patients hospitalized in a medical non-intensive care ward..

Exclusion Criteria:

  • pregnant or lactating women;
  • adults subject to legal protection (safeguarding of justice, guardianship, guardianship), persons deprived of their liberty.

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Group 1
patients with cardiac surgery with CBP. Blood samples in the operating room, 5 to 10 minutes after neutralization of heparin by protamine
Biological: measurement of anti-Xa activities

The measurement of anti-Xa activities will be carried out on frozen-defrosted plasma citrate and CTAD with 4 reagents

  • STA-Liquid anti-Xa (STAGO) (not containing dextran)
  • Biophen Heparin LRT (Hyphen) (reactive containing dextran)
  • Berichrom (Siemens) with dextran
  • Berichrom (Siemens) without dextran

The dosage of platelet factor 4 and of the beta-TG will be carried out on frozen-defrosted plasma with the asserachrom PF4 and Asserachrom beta-TG (Diagnostica Stago) kits.

Other Names:
  • dosage of platelet factor 4 and of the beta-TG
Group 2
patients who had cardiac surgery with CBP, between day 1 and day 5 after surgery.
Biological: measurement of anti-Xa activities

The measurement of anti-Xa activities will be carried out on frozen-defrosted plasma citrate and CTAD with 4 reagents

  • STA-Liquid anti-Xa (STAGO) (not containing dextran)
  • Biophen Heparin LRT (Hyphen) (reactive containing dextran)
  • Berichrom (Siemens) with dextran
  • Berichrom (Siemens) without dextran

The dosage of platelet factor 4 and of the beta-TG will be carried out on frozen-defrosted plasma with the asserachrom PF4 and Asserachrom beta-TG (Diagnostica Stago) kits.

Other Names:
  • dosage of platelet factor 4 and of the beta-TG
Group 3
hospitalized patients in intensive care unit, including patients on extracorporeal life support (ECLS).
Biological: measurement of anti-Xa activities

The measurement of anti-Xa activities will be carried out on frozen-defrosted plasma citrate and CTAD with 4 reagents

  • STA-Liquid anti-Xa (STAGO) (not containing dextran)
  • Biophen Heparin LRT (Hyphen) (reactive containing dextran)
  • Berichrom (Siemens) with dextran
  • Berichrom (Siemens) without dextran

The dosage of platelet factor 4 and of the beta-TG will be carried out on frozen-defrosted plasma with the asserachrom PF4 and Asserachrom beta-TG (Diagnostica Stago) kits.

Other Names:
  • dosage of platelet factor 4 and of the beta-TG
Group 4
patients hospitalized in a medical non-intensive care ward.
Biological: measurement of anti-Xa activities

The measurement of anti-Xa activities will be carried out on frozen-defrosted plasma citrate and CTAD with 4 reagents

  • STA-Liquid anti-Xa (STAGO) (not containing dextran)
  • Biophen Heparin LRT (Hyphen) (reactive containing dextran)
  • Berichrom (Siemens) with dextran
  • Berichrom (Siemens) without dextran

The dosage of platelet factor 4 and of the beta-TG will be carried out on frozen-defrosted plasma with the asserachrom PF4 and Asserachrom beta-TG (Diagnostica Stago) kits.

Other Names:
  • dosage of platelet factor 4 and of the beta-TG

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assess the effect of different reagents containing or not dextran sulphate, on the measurement of anti-Xa for different groups of patients
Time Frame: 5 days
Measure of anti-Xa activity in CTAD plasma
5 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To define factors that influence the results of the biological test "anti-Xa" activity :type of anticoagulant (CTAD or citrate) .
Time Frame: 5 days
Measure of anti-Xa activity
5 days
To define factors that influence the results of the biological test "anti-Xa" activity :concentration of platelet factor 4 (PF4) and beta-TG present in plasma
Time Frame: 5 days
Measure of anti-Xa activity
5 days
To define factors that influence the results of the biological test "anti-Xa" activity :Patient characteristics including age and sex and if available, creatinine clearance, antithrombin, fibrinogen, platelet count
Time Frame: 5 days
Measure of anti-Xa activity
5 days
To define factors that influence the results of the biological test "anti-Xa" activity :The indication of treatment
Time Frame: 5 days
Measure of anti-Xa activity
5 days

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rennes University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Isabelle Gouin, Rennes University Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 16, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 16, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 16, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 35RC19_3001_DEXHEP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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