Platelet FunctionMULPPNCT01881698
Evaluation of Platelet Function in Pregnancy With Multiple Electrode Aggregometry
An observational study of Platelet Function and Pregnancy, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Establishment of a range of normal values in pregnancy with the Multiple Electrode Aggregometry (Multiplate@) device, a device that allows measurement of not only platelet count but platelet function. This has not been studied in ths special patient group. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Platelet Function, Pregnancy
- What is being tested?
- Platelet function during pregnancy Multiple Electrode Aggregometry (Multiplate@) device
- How many people
- 200 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2013to May 2015
- How long will I take part?
- 7 Months
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant patients above the age of majority
Who may be able to join
- pregnancy
Who cannot join
- Rejection of informed consent
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Universitätsklinik für Frauenheilkunde, Allgemeines Krankenhaus der Stadt Wien
Vienna, State of Vienna, 1090
About this study
Official title: Multiple Electrode Aggregometry and Platelet Function in Pregnancy
Establishment of a range of normal values in pregnancy with the Multiple Electrode Aggregometry (Multiplate@) device, a device that allows measurement of not only platelet count but platelet function. This has not been studied in ths special patient group. Results from this trial will be used as a basis for further investigation of abnormal platelet function in pregnancy.
- Conditions
- Platelet Function, Pregnancy
- Being tested
- Platelet function during pregnancy Multiple Electrode Aggregometry (Multiplate@) device
- Keywords
- pregnancy, platelet function, monitoring, multiple electrode aggregometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet function during pregnancy Multiple Electrode Aggregometry (Multiplate@) deviceOther
Observation of platelet function in pregnancy
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of platelet function
Measurement of change of platelet function by the Multiplate® device. First measurement (baseline measurement) at enrollment into the trial. Second measurement during government-mandated gynaecological evaluation, around the 20th week of pregnancy.
Third measurement immediately prior to delivery. Last measurement one week after delivery. 2nd, 3rd and 4th measurement for assessment of change from baseline.
Measured: 4x, as specified below
Secondary outcomes (1)
Platelet-associated complications
Record of bleeding events, preeclampsia, HELLP (hemolysis, elevated liver enzymes, and low platelet count) syndrome.
Time points: at every assessment of primary outcome measure, as described above.
Measured: 4x, as specified below (baseline, 20th week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2013 (estimated)
- Study startOct 2013
- Primary completionMay 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet FunctionStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 7 Months
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reinhard Hahn, Medical University of Vienna
- Investigators
- Reinhard Hahn, MD, Principal investigator, Department of Anaesthesia, General Intensive Care and Pain Management, Medical University Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01881698
- Sponsor's protocol ID
- 1426/2013
- Acronym
- MULPP
- Status last verified
- Oct 2013
- First submitted
- 17 May 2013
- Last updated
- 11 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Electrode Aggregometry and Platelet Function in Pregnancy
- ClinicalTrials.gov ID
- NCT01881698
- Acronym / sponsor ID
- MULPP / 1426/2013
- Conditions
- Platelet Function, Pregnancy
- Keywords
- pregnancy, platelet function, monitoring, multiple electrode aggregometry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 20 Jun 2013 (estimated)
- 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.
Establishment of a range of normal values in pregnancy with the Multiple Electrode Aggregometry (Multiplate@) device, a device that allows measurement of not only platelet count but platelet function. This has not been studied in ths special patient group. Results from this trial will be used as a basis for further investigation of abnormal platelet function in pregnancy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant patients above the age of majority
Key inclusion criteria (1 listed)
- pregnancy
Key exclusion criteria (1 listed)
- Rejection of informed consent
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 |
|---|---|---|
| Platelet function during pregnancy Multiple Electrode Aggregometry (Multiplate@) deviceObservation of platelet function in pregnancy | Other | – |
Primary outcome
Change of platelet function
Time frame: 4x, as specified below
Measurement of change of platelet function by the Multiplate® device. First measurement (baseline measurement) at enrollment into the trial. Second measurement during government-mandated gynaecological evaluation, around the 20th week of pregnancy. Third measurement immediately prior to delivery. Last measurement one week after delivery. 2nd, 3rd and 4th measurement for assessment of change from baseline.
1 secondary outcome
Platelet-associated complications
Time frame: 4x, as specified below (baseline, 20th week)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2013.
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Cookies for Platelets
Blood Donation
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.
Reinhard Hahn, MD principal investigator
Department of Anaesthesia, General Intensive Care and Pain Management, Medical University Vienna
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 Platelet Function and Pregnancy, run by Medical University of Vienna at 1 site in Austria.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 11 Oct 2013. 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 Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Reinhard Hahn, MD (0043 1 40400 ext. 4100, reinhard.hahn@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of platelet function (time frame: 4x, as specified below). 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 11 Oct 2013.