Brain Imaging After Non-traumatic Intracranial Hemorrhage (SAVEBRAINPWI) (SAVEBRAINPWI)

February 20, 2024 updated by: Erasme University Hospital

Prospective Assessment of Brain Imaging After Aneurysmal of AVM-related Intracranial Hemorrhage

The study is an observational prospective evaluation of an approved and unchanged clinical management, evaluating different diagnosis methods to assess brain perfusion in patients with an aneurysmal or AVM-related intracranial hemorrhage

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study is a prospective description and evaluation of an approved and unchanged clinical management, evaluating already used different diagnosis methods to assess brain perfusion in patients with atraumatic (aneurysmal, AVM-related, unknown cause) intracranial hemorrhage.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients who fit the inclusion criteria (suffered a non-traumatic (aneurysmal, AVM-related, unknown cause) intracranial hemorrhage) will be included prospectively.

The deadline for data collection November, 2031 Data analysis will be performed when judged necessary by the investigators.

Description

i. Inclusion Criteria

  1. Age ≥ 18 years
  2. Non-traumatic intracranial hemorrhage (subarachnoid hemorrhage secondary to a ruptured aneurysm or AVM, unknown cause, per procedural bleed)
  3. In case of ruptured aneurysm, AVM or other etiology : need to be secured with surgical clipping or endovascular intervention if judged possible
  4. No contra-indication to perfusion imaging
  5. Subject or legal representative is able and willing to give informed consent.

ii. Exclusion Criteria

  1. Traumatic intracranial hemorrhage
  2. Contra-indication to imaging or patient's refusal.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Evolution of brain imaging in Non-traumatic Intracranial Hemorrhage
This study will use an established local protocol for DCI and intracranial arterial vasospastic stenosis screening, and follow-up to make sure that all patients have the same protocol and don't lose any chance of improvement and good outcome
Diagnostic test: Brain computed tomography
This study will use an established local protocol for DCI and intracranial arterial vasospastic stenosis screening, and follow-up to make sure that all patients have the same protocol and don't lose any chance of improvement and good outcome : CT perfusion at different time intervals

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in brain hypoperfusion
Time Frame: Change between day 0, 5, 9 after Intracranial Hemorrhage
Brain hypoperfusion in arterial territories assessed by the delays on perfusion Time to drain (seconds) on CT and/or MR perfusion
Change between day 0, 5, 9 after Intracranial Hemorrhage

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to next endovascular intervention for vasospastic stenosis
Time Frame: Number of days after the endovascular procedure until the next procedure in days, up to 4 weeks
Delay between two procedures for the same indication
Number of days after the endovascular procedure until the next procedure in days, up to 4 weeks
Change in vessel size
Time Frame: Change between day 0, 5, 9 after Intracranial Hemorrhage
Change in the vessel size measured on digital subtraction angiography (DSA) and computed tomography angiogram (CTA) in millimeters
Change between day 0, 5, 9 after Intracranial Hemorrhage
Transcranial Doppler
Time Frame: Change between day 0, 5, 9 after Intracranial Hemorrhage
Reduction in intracranial vasospasm assessed by the targeted vessel velocity in meters per second
Change between day 0, 5, 9 after Intracranial Hemorrhage
Brain Hypoperfusion 2
Time Frame: Change between day 0, 5, 9 after Intracranial Hemorrhage
Reduction in brain hypoperfusion assessed by the volumes on different perfusion parameters time to peak (in seconds) on CT and/or MR perfusion
Change between day 0, 5, 9 after Intracranial Hemorrhage
Change in Glasgow coma scale
Time Frame: Change between day 0, 5, 9 after Intracranial Hemorrhage
Glasgow coma scale (GCS between 3 and 15, a higher score means a better outcome)
Change between day 0, 5, 9 after Intracranial Hemorrhage
Change in National Institutes of Health Stroke Scale score
Time Frame: Change between day 0, 5, 9 after Intracranial Hemorrhage
National Institutes of Health Stroke Scale (NIHSS between 0 and 42, a higher score means a worse outcome)
Change between day 0, 5, 9 after Intracranial Hemorrhage
Change in the monitoring of tissue oxygen pressure (PtiO2)
Time Frame: Change between day 0, 5, 9 after Intracranial Hemorrhage
Monitoring of tissue oxygen pressure (PtiO2)
Change between day 0, 5, 9 after Intracranial Hemorrhage
Change in the number of new ischemic lesions
Time Frame: Change between day 0, 5, 9, 21 after Intracranial Hemorrhage
Number of new ischemic lesions on non-contrast CT scan
Change between day 0, 5, 9, 21 after Intracranial Hemorrhage
modified Rankin Scale at 3 months
Time Frame: 3 months after Intracranial Hemorrhage
clinical evolution (mRS between 0 and 6, a higher score means a worse outcome)
3 months after Intracranial Hemorrhage
Change in brain hypoperfusion 3
Time Frame: Change between day 0, 5, 9 after Intracranial Hemorrhage
Brain hypoperfusion in arterial territories assessed by the delays on perfusion parameters TMax maps in seconds on CT and/or MR perfusion
Change between day 0, 5, 9 after Intracranial Hemorrhage
Change in brain hypoperfusion 4
Time Frame: Change between day 0, 5, 9 after Intracranial Hemorrhage
Brain hypoperfusion in arterial territories assessed by the delays on perfusion parameters Mean transit time on CT and/or MR perfusion in seconds
Change between day 0, 5, 9 after Intracranial Hemorrhage

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Erasme University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Adrien Guenego, MD, Erasme University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 20, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 15, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 14, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SRB2021298

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No data sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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