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NCT Number: NCT06033378

Blood Pressure Treatment in ICU Patients with Subarachniodal Haemorrhage.

An MRI study to examine the relationship between blood pressure and cerebral blood flow in patients with subarachnoidal hemorrhage and suspect or verified vasospasm.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Umeå University Hospital

Umeå, Sweden

Location status: Recruiting

Location contact

Laleh Zarrinkoob, MD, PhD

CONTACT

[email protected]

+46707567067

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Coiled or clipped aneurysm
  • Suspected or confirmed vasospasm

Exclusion criteria

  • 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

Treatment and study plan

Blood pressure elevation

Other

Increasing systemic blood pressure for measurement of cerebral blood flow changes

Primary outcomes

  1. Cerebral blood flow

    Time frame: 1 hour

    mL/min as measured by MRI

Study contacts

Contact information is provided by the study sponsor or research team.

Laleh Zarrinkoob, MD, PhD

CONTACT

[email protected]

+46707567067

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

  • Region Västerbotten

Registry information

Official study title

Blood Pressure Treatment in ICU Patients with Subarachniodal Haemorrhage. -Can Blood Pressure Be Used As a Surrogate Marker for Blood Flow

Acronym: BFBP

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Sep 13, 2023
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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