Magnesium and Platelet Function Testing

Completed

• Conditions: Eclampsia Preeclampsia
• Interventions: Other: Collect a study-specific blood sample of healthy subjects

• Registration Number: NCT03143647
• Lead Sponsor: Ziekenhuis Oost-Limburg

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-26
• Study First Submitted QC: 2017-05-03
• Study First Posted: 2017-05-08
• Study Start: 2017-06-09
• Primary Completion: 2017-07-30
• Study Completion: 2017-09-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-12
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case	Collect a study-specific blood sample of healthy subjects	* Female * Pregnant with possible pre-eclampsia * Over 18 years of age * American Society of Anesthesiologists physical fitness scale 1
Control	Collect a study-specific blood sample of healthy subjects	* Female * Over 18 years of age * American Society of Anesthesiologists physical fitness scale 1 * Not pregnant

Primary Outcome Measures

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

Trial Locations

Locations (1)

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Belgium