Magnesium and Platelet Function Testing

Eclampsia Preeclampsia Clinical Trial

— MgCedVD  

Official title:

Influence of Therapeutic Magnesium on Platelet Function Testing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03143647
• Other study ID #: CTU2017140
• Status: Completed
• Start date: June 9, 2017
• Est. completion date: September 1, 2017

Study information

• Verified date: April 2023
• Source: Ziekenhuis Oost-Limburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 1, 2017
• Est. primary completion date: July 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Eclampsia
• Eclampsia Preeclampsia
• Pre-Eclampsia

Intervention

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.

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk

Sponsors (2)

Lead Sponsor	Collaborator
Ziekenhuis Oost-Limburg	Maastricht University

Country where clinical trial is conducted

Belgium, 

Outcome

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