Blood PressureBFBPNCT06033378
Blood Pressure Treatment in ICU Patients with Subarachniodal Haemorrhage.
A study testing Blood pressure elevation in people with Blood Pressure and Subarachnoid Hemorrhage, run by Umeå University at 1 site in Sweden.
Trial summary
An MRI study to examine the relationship between blood pressure and cerebral blood flow in patients with subarachnoidal hemorrhage and suspect or verified vasospasm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure, Subarachnoid Hemorrhage, Aneurysm Cerebral
- What is being tested?
- Blood pressure elevation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2023to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Coiled or clipped aneurysm
- Suspected or confirmed vasospasm
Who cannot join
- BMI >30
- Pregnancy
- Pacemaker or other MRI contraindications
- Severe congestive heart failure (NYHA III-IV) or cardiac arrhythmia.
- Severe respiratory failure or FiO2 >0.6
- Severe kidney failure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Umeå University Hospital
Umeå
Laleh Zarrinkoob, MD, PhD, +46707567067, laleh.zarrinkoob@umu.se
About this study
Official title: Blood Pressure Treatment in ICU Patients with Subarachniodal Haemorrhage. -Can Blood Pressure Be Used As a Surrogate Marker for Blood Flow
An MRI study to examine the relationship between blood pressure and cerebral blood flow in patients with subarachnoidal hemorrhage and suspect or verified vasospasm.
Read the detailed description
Subarachnoidal hemorrhage (SAH) is a type of stroke with high mortality rates and often requires care at the intensive care unit. Cerebral blood flow (CBF) needs to be ensured so that the brain receives optimal nourishment, and this is largely controlled by regulating blood pressure (BP) using medications that affect the heart and blood vessels. Approximately 3-7 days after SAH onset, vasospasm (SAH-V) can occur. Treatment usually includes maintaining blood pressure (BP) above a certain threshold to achieve adequate cerebral blood flow (CBF). An important component of raising BP is increasing vascular resistance using vasoconstrictive medications, which paradoxically can decrease CBF.
The study objective is to investigate the correlation between BP changes and their impact on CBF in patients with suspect or verified SAH-V using MRI.
To achieve this purpose, the investigators plan to examine the relationship between BP and CBF in patients with SAH-V who require neuro-intensive care. To measure CBF, two techniquis will be used: phase-contrast MRI and arterial spin labeling.
Flow measurement with MRI:
- Baseline images will be acquired at baseline blood pressure.
- Mean arterial pressure (MAP) will be increased using norepinephrine. New images will be acquired when MAP is increased by approximately 20-30% from the baseline.
All BP levels will be maintained within clinically acceptable ranges. All data will be recorded in the patient's medical record, and MRI images will be processed at a later stage.
- Conditions
- Blood Pressure, Subarachnoid Hemorrhage, Aneurysm Cerebral
- Being tested
- Blood pressure elevation
- Keywords
- magnetic resonance imaging, norepinephrine, blood flow
- Medical subject headings
- Subarachnoid Hemorrhage, Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood pressure elevationOther
Increasing systemic blood pressure for measurement of cerebral blood flow changes
| Study group | Role | What they receive |
|---|---|---|
| Cerebral blood flow | Experimental | Change in cerebral blood flow with increased systemic blood pressure Receives: Other: Blood pressure elevation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral blood flow
mL/min as measured by MRI
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Sep 2023
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Region Västerbotten
- Responsible party
- Sponsor
- Investigators
- Laleh Zarrinkoob, Principal investigator, Region Västerbotten
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06033378
- Sponsor's protocol ID
- 2022-06754-01
- Acronym
- BFBP
- Status last verified
- Feb 2025
- First submitted
- 4 Sep 2023
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Osterlind J, Birnefeld J, Birnefeld E, Hultin M, Qvarlander S, Wahlin A, Holmlund P, Zarrinkoob L. Study protocol: MRI-based assessment of cerebral blood flow under pharmacologically elevated blood pressure in patients under general anesthesia, and in sedated ICU patients with aneurysmal subarachnoid hemorrhage. PLoS One. 2025 Dec 10;20(12):e0338688. doi: 10.1371/journal.pone.0338688. eCollection 2025.
PubMed 41370289
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Pressure Treatment in ICU Patients with Subarachniodal Haemorrhage. -Can Blood Pressure Be Used As a Surrogate Marker for Blood Flow
- ClinicalTrials.gov ID
- NCT06033378
- Acronym / sponsor ID
- BFBP / 2022-06754-01
- Conditions
- Blood Pressure, Subarachnoid Hemorrhage, Aneurysm Cerebral
- Keywords
- magnetic resonance imaging, norepinephrine, blood flow
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Region Västerbotten
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 13 Sep 2023 (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.
An MRI study to examine the relationship between blood pressure and cerebral blood flow in patients with subarachnoidal hemorrhage and suspect or verified vasospasm.
Detailed description
Subarachnoidal hemorrhage (SAH) is a type of stroke with high mortality rates and often requires care at the intensive care unit. Cerebral blood flow (CBF) needs to be ensured so that the brain receives optimal nourishment, and this is largely controlled by regulating blood pressure (BP) using medications that affect the heart and blood vessels. Approximately 3-7 days after SAH onset, vasospasm (SAH-V) can occur. Treatment usually includes maintaining blood pressure (BP) above a certain threshold to achieve adequate cerebral blood flow (CBF). An important component of raising BP is increasing vascular resistance using vasoconstrictive medications, which paradoxically can decrease CBF.
The study objective is to investigate the correlation between BP changes and their impact on CBF in patients with suspect or verified SAH-V using MRI.
To achieve this purpose, the investigators plan to examine the relationship between BP and CBF in patients with SAH-V who require neuro-intensive care. To measure CBF, two techniquis will be used: phase-contrast MRI and arterial spin labeling.
Flow measurement with MRI:
- Baseline images will be acquired at baseline blood pressure.
- Mean arterial pressure (MAP) will be increased using norepinephrine. New images will be acquired when MAP is increased by approximately 20-30% from the baseline.
All BP levels will be maintained within clinically acceptable ranges. All data will be recorded in the patient's medical record, and MRI images will be processed at a later stage.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cerebral blood flow | Experimental | Other: Blood pressure elevationChange in cerebral blood flow with increased systemic blood pressure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Coiled or clipped aneurysm
- Suspected or confirmed vasospasm
Key exclusion criteria (6 listed)
- BMI >30
- Pregnancy
- Pacemaker or other MRI contraindications
- Severe congestive heart failure (NYHA III-IV) or cardiac arrhythmia.
- Severe respiratory failure or FiO2 >0.6
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 |
|---|---|---|
| Blood pressure elevationIncreasing systemic blood pressure for measurement of cerebral blood flow changes | Other | Cerebral blood flow |
Primary outcome
Cerebral blood flow
Time frame: 1 hour
mL/min as measured by MRI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Derived from this study: PubMed 41370289Osterlind J, Birnefeld J, Birnefeld E, Hultin M, Qvarlander S, Wahlin A, Holmlund P, Zarrinkoob L. Study protocol: MRI-based assessment of cerebral blood flow under pharmacologically elevated blood pressure in patients under general anesthesia, and in sedated ICU patients with aneurysmal subarachnoid hemorrhage. PLoS One. 2025 Dec 10;20(12):e0338688. doi: 10.1371/journal.pone.0338688. eCollection 2025.
- 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.
Laleh Zarrinkoob principal investigator
Region Västerbotten
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood pressure elevation in people with Blood Pressure and Subarachnoid Hemorrhage, run by Umeå University at 1 site in Sweden.
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 6 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: looking for participants now, as of the sponsor's last update on 13 Mar 2025. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laleh Zarrinkoob, MD, PhD (+46707567067, laleh.zarrinkoob@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral blood flow (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06033378, which also lists 1 linked publication.
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 13 Mar 2025.