Magnesium and Platelet Function Testing

NCT03143647 | Completed

• 1 other identifier: CTU2017140
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Eclampsia Preeclampsia

Outcome Measures

Primary Outcomes (1)

• PAC-t-UB test results

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

  4 months

Study Arms (2)

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

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

Interventions

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.

Also known as: Collect an extra blood sample of pregnant woman during a routine control with an already planned blood sample collection

Case; Control

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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, ..)

You may qualify if:

• 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, ..)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ziekenhuis Oost-Limburg: lead
• Maastricht University: collaborator

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

Location

Study Officials

• Dieter Mesotten, MD

  Ziekenhuis Oost-Limburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 26, 2017
• First Posted: May 8, 2017
• Study Start: June 9, 2017
• Primary Completion: July 30, 2017
• Study Completion: September 1, 2017
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)