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Completed

NCT Number: NCT03143647

Magnesium and 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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collect a study-specific blood sample of healthy subjects

Other

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

Primary outcomes

  1. PAC-t-UB test results

    Time frame: 4 months

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

Sponsors and collaborators

Lead sponsor

Ziekenhuis Oost-Limburg

Other

Collaborators

  • Maastricht University

Registry information

Official study title

Influence of Therapeutic Magnesium on Platelet Function Testing

Acronym: MgCedVD

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 8, 2017
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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