Intraparenchimal Cerebral HaemorrhageBP-MONICHNCT01956292
Continuous Monitoring of Blood Pressure in Spontaneous Intraparenchimal Cerebral Haemorrhage
An observational study of Intraparenchimal Cerebral Haemorrhage, run by Azienda Ospedaliera Sant'Anna at 1 site in Italy.
Trial summary
Evaluation of blood pressure variability in the acute phase of intraparenchimal cerebral haemorrhage and its consequences to clinical outcome Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraparenchimal Cerebral Haemorrhage
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2013to Jun 2015
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to hospital for intraparenchimal cerebral haemorrhage
Who may be able to join
- hospitalization only for spontaneous intraparenchimal cerebral haemorrhage
- age over 18 years
Who cannot join
- cerebral haemorrhage secondary to other causes
Trial locations and contacts
1 site in 1 country.
Italy1 site
AO Sant'Anna Hospital
Como, Como, 22100
Simone Vidale, MD, 00390315859282, simone.vidale@hsacomo.org
About this study
Official title: Observational Study of Continous Monitoring of Arterial Blood Pressure in Spontaneous Intraparenchimal Cerebral Haemorrhage
Evaluation of blood pressure variability in the acute phase of intraparenchimal cerebral haemorrhage and its consequences to clinical outcome
- Conditions
- Intraparenchimal Cerebral Haemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intraparenchimal cerebral haemorrhage | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of blood pressure varibility on clinical course in patients with cerebral haemorrhage
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2014 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraparenchimal Cerebral HaemorrhageStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Sant'Anna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simone Vidale, Azienda Ospedaliera Sant'Anna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01956292
- Sponsor's protocol ID
- OSA-0002
- Acronym
- BP-MONICH
- Status last verified
- Oct 2013
- First submitted
- 29 Sep 2013
- Last updated
- 8 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Continous Monitoring of Arterial Blood Pressure in Spontaneous Intraparenchimal Cerebral Haemorrhage
- ClinicalTrials.gov ID
- NCT01956292
- Acronym / sponsor ID
- BP-MONICH / OSA-0002
- Conditions
- Intraparenchimal Cerebral Haemorrhage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Sant'AnnaUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 8 Oct 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.
Evaluation of blood pressure variability in the acute phase of intraparenchimal cerebral haemorrhage and its consequences to clinical outcome
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraparenchimal cerebral haemorrhage | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to hospital for intraparenchimal cerebral haemorrhage
Key inclusion criteria (2 listed)
- hospitalization only for spontaneous intraparenchimal cerebral haemorrhage
- age over 18 years
Key exclusion criteria (1 listed)
- cerebral haemorrhage secondary to other causes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
evaluation of blood pressure varibility on clinical course in patients with cerebral haemorrhage
Time frame: Day 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2013.
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.
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 Intraparenchimal Cerebral Haemorrhage, run by Azienda Ospedaliera Sant'Anna at 1 site in Italy.
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 2 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 8 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 Italy. 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 Simone Vidale, MD (00390315859282, simone.vidale@hsacomo.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluation of blood pressure varibility on clinical course in patients with cerebral haemorrhage (time frame: Day 7). 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 8 Oct 2013; AzTrials last refreshed its copy on 8 Nov 2026.