Magnesium and Platelet Function Testing (MgCedVD)

Influence of Therapeutic Magnesium on Platelet Function Testing

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.

Study Overview

• Status: Completed
• Conditions: Eclampsia Preeclampsia
• Intervention / Treatment: Other: Collect a study-specific blood sample of healthy subjects

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Belgium
  • Genk, Belgium, 3600
    • Ziekenhuis Oost-Limburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Females over 18 years of age (and younger or equal to 50 years of age) that meet the American Society of Anesthesiologists physical fitness scale 1 (non smoker, no or minimal alcohol use, ..)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PAC-t-UB test results	The main endpoint of this study is the Platelet Activation Test in Unprocessed Blood (PAC-t-UB).	4 months

Collaborators and Investigators

• Sponsor: Ziekenhuis Oost-Limburg
• Collaborators: Maastricht University
• Investigators: Principal Investigator: Dieter Mesotten, MD, Ziekenhuis Oost-Limburg

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2017
• Primary Completion (Actual): July 30, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: April 26, 2017
• First Submitted That Met QC Criteria: May 3, 2017
• First Posted (Actual): May 8, 2017

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Eclampsia; Pre-Eclampsia
• Other Study ID Numbers: CTU2017140

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No