Magnesium and Platelet Function Testing

NCT ID: NCT03143647

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-09
• Study Completion Date: 2017-09-01

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Control

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

Collect a study-specific blood sample of healthy subjects

Intervention Type: 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.

Case

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

Collect a study-specific blood sample of healthy subjects

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

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

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Maastricht University

OTHER

Sponsor Role: collaborator

Ziekenhuis Oost-Limburg

OTHER

Sponsor Role: lead

Responsible Party

Dieter Mesotten

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dieter Mesotten, MD

Role: PRINCIPAL_INVESTIGATOR

Ziekenhuis Oost-Limburg

Locations

Ziekenhuis Oost-Limburg

Genk, , Belgium

Countries

Belgium

Other Identifiers

CTU2017140

Identifier Type: -

Identifier Source: org_study_id