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MgCedVD: Magnesium and Platelet Function Testing

Sponsor
Ziekenhuis Oost-Limburg (Other)
Overall Status
Completed
CT.gov ID
NCT03143647
Collaborator
Maastricht University (Other)
20
Enrollment
1
Location
2.8
Actual Duration (Months)
7.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Magnesium has built up the reputation of a 'natural calcium antagonist'. However, the exact effect of magnesium on coagulation and more specifically on platelet function is still disputed. An important discrepancy between in vivo and in vitro studies exists. Magnesium has thus been reported to antagonize platelets in some studies, and to stimulate platelets in other studies. Current evidence seems to point in the direction of a general antagonization of aggregation and coagulation.

Intravenous magnesium is often administered in pre-eclampsia as seizure prophylaxis. Therapeutic regimens usually consist of an intravenously administered loading dose (2-3 grams) and a maintenance infusion, targeting a plasma level of 2-3 mmol/L. Therapeutic drug monitoring is needed, as magnesium toxicity is an important concern.

Condition or Disease Intervention/Treatment Phase
  • Other: Collect a study-specific blood sample of healthy subjects

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
20 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Influence of Therapeutic Magnesium on Platelet Function Testing
Actual Study Start Date :
Jun 9, 2017
Actual Primary Completion Date :
Jul 30, 2017
Actual Study Completion Date :
Sep 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Control

Female Over 18 years of age American Society of Anesthesiologists physical fitness scale 1 Not pregnant

Other: Collect a study-specific blood sample of healthy subjects
One heparin tube (4ml) and one hirudin tube (4ml) blood sample will be collected through standard venipuncture. After applying a tourniquet with moderate pressure around the arm of the patient's choice, skin will be disinfected over a suitable vein in the elbow or fore-arm. A hirudin and a heparin tube will be filled with venous blood through a single puncture with a 22 Ga needle (manufacturer, location). After release of the tourniquet, bleeding will be stopped by applying local pressure for 5 minutes with a sterile gauze.
Other Names:
  • Collect an extra blood sample of pregnant woman during a routine control with an already planned blood sample collection

    		•
    Case

    Female Pregnant with possible pre-eclampsia Over 18 years of age American Society of Anesthesiologists physical fitness scale 1

    Other: Collect a study-specific blood sample of healthy subjects
    One heparin tube (4ml) and one hirudin tube (4ml) blood sample will be collected through standard venipuncture. After applying a tourniquet with moderate pressure around the arm of the patient's choice, skin will be disinfected over a suitable vein in the elbow or fore-arm. A hirudin and a heparin tube will be filled with venous blood through a single puncture with a 22 Ga needle (manufacturer, location). After release of the tourniquet, bleeding will be stopped by applying local pressure for 5 minutes with a sterile gauze.
    Other Names:
  • Collect an extra blood sample of pregnant woman during a routine control with an already planned blood sample collection

    		•

    Outcome Measures

    Primary Outcome Measures

    1. PAC-t-UB test results [4 months]

      The main endpoint of this study is the Platelet Activation Test in Unprocessed Blood (PAC-t-UB).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Signed Informed consent

    • Over 18 years of age (and younger or equal to 50 years of age) and able to provide legally binding consent

    • American Society of Anesthesiologists physical fitness scale 1 (non smoker, no or minimal alcohol use, ..)

    Exclusion Criteria:

    • Chronic disease

    • Chronic medical therapy (other than oral contraception)

    • Pregnancy

    • ASA 2 or higher

    • Known coagulation or aggregation disorders

    • Use of COX-inhibitors in the last 10 days

    • Contra-indications for venipuncture

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ziekenhuis Oost-Limburg Genk Belgium 3600

    Sponsors and Collaborators

    • Ziekenhuis Oost-Limburg
    • Maastricht University

    Investigators

    • Principal Investigator: Dieter Mesotten, MD, Ziekenhuis Oost-Limburg

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ziekenhuis Oost-Limburg
    ClinicalTrials.gov Identifier:
    NCT03143647
    Other Study ID Numbers:
    • CTU2017140
    First Posted:
    May 8, 2017
    Last Update Posted:
    Mar 7, 2019
    Last Verified:
    Mar 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pre-Eclampsia
    Eclampsia

    Study Results

    No Results Posted as of Mar 7, 2019