Eclampsia PreeclampsiaMgCedVDNCT03143647
Magnesium and Platelet Function Testing
An observational study of Eclampsia Preeclampsia, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Eclampsia Preeclampsia
- What is being tested?
- Collect a study-specific blood sample of healthy subjects
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 9 Jun 2017to 1 Sep 2017
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
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, ..)
Who may be able to join
- 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, ..)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Therapeutic Magnesium on 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.
- Conditions
- Eclampsia Preeclampsia
- Being tested
- Collect a study-specific blood sample of healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collect a study-specific blood sample of healthy subjectsOther
Also called Collect an extra blood sample of pregnant woman during a routine control with an already planned blood sample collection
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | * Female
* Over 18 years of age
* American Society of Anesthesiologists physical fitness scale 1
* Not pregnant Receives: 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 Receives: Other: Collect a study-specific blood sample of healthy subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
PAC-t-UB test results
The main endpoint of this study is the Platelet Activation Test in Unprocessed Blood (PAC-t-UB).
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start9 Jun 2017
- Primary completion30 Jul 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eclampsia PreeclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University
- Responsible party
- Principal investigator, Dieter Mesotten, Ziekenhuis Oost-Limburg
- Investigators
- Dieter Mesotten, MD, Principal investigator, Ziekenhuis Oost-Limburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03143647
- Sponsor's protocol ID
- CTU2017140
- Acronym
- MgCedVD
- Status last verified
- Apr 2023
- First submitted
- 26 Apr 2017
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Therapeutic Magnesium on Platelet Function Testing
- ClinicalTrials.gov ID
- NCT03143647
- Acronym / sponsor ID
- MgCedVD / CTU2017140
- Conditions
- Eclampsia Preeclampsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ziekenhuis Oost-LimburgUniversity, hospital or other
- Collaborators
- Maastricht University
- Study start
- 9 Jun 2017 (actual)
- Primary completion
- 30 Jul 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 8 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Other: 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 |
| Case | – | Other: 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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, ..)
Key inclusion criteria (3 listed)
- 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, ..)
Key exclusion criteria (7 listed)
- Chronic disease
- Chronic medical therapy (other than oral contraception)
- Pregnancy
- ASA 2 or higher
- Known coagulation or aggregation disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collect a study-specific blood sample of healthy subjectsAlso: Collect an extra blood sample of pregnant woman during a routine control with an already planned blood sample collectionOne 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 | Case, Control |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dieter Mesotten, MD principal investigator
Ziekenhuis Oost-Limburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eclampsia Preeclampsia, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PAC-t-UB test results (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.