NeurosurgeryHemoStopArtNCT05874050
Arterial Pressure and Surgical Hemostasis in Elective Neurosurgery.
An observational study of Neurosurgery and Intracranial Hemorrhages, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 1 site in Italy.
Trial summary
The objective of this observational study is to examine the impact of augmented arterial pressure during the hemostatic phase of elective supratentorial neurosurgery. The primary inquiries it seeks to address are as follows: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurosurgery, Intracranial Hemorrhages, Supratentorial Brain Tumor
- How many people
- 160 participants
- Where
- 1 siteItaly
- Study dates
- 11 Nov 2022to 31 Dec 2023
- 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: All consecutive adult patients scheduled to undergo elective supratentorial neurosurgical surgery.
Who may be able to join
- All consecutive adult patients scheduled to undergo elective supratentorial neurosurgical surgery.
Who cannot join
- Urgent or emergent surgery
- Neurovascular surgery
- Subtentorial surgery
- Trans nasal approaches
- Back surgery
- Acute or chronic kidney injury as defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines (Kellum \& Lameire, 2013; Stevens \& Levin, 2013)
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- Coagulation derangement (platelet count < 100*10^9/L, international normalized ratio (INR) or activated partial thromboplastin time (aPTT) > 1.5 times the normal laboratory range) or anticoagulant/antiplatelet treatment without appropriate withhold intervals, as per existing guidelines
- Preoperative severe hemodynamic instability, according to the judgment of the attending physician
- Age < 18 years
- Pregnancy or breastfeeding
- Absence of informed consent
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Istituto Neurologico C. Besta
Milan, Milano, 200133
About this study
Official title: The Effect of Arterial Pressure on Surgical Hemostasis During Elective Supratentorial Neurosurgery: a Prospective Observational Study.
The objective of this observational study is to examine the impact of augmented arterial pressure during the hemostatic phase of elective supratentorial neurosurgery. The primary inquiries it seeks to address are as follows:
- Does an increase in systolic arterial pressure prompt a hemostatic maneuver by the neurosurgeon, and does the concomitant mean arterial pressure value influence the frequency of such interventions?
- How often do postoperative intracranial hemorrhages occur, and how severe are they in relation to the achieved mean arterial pressure value?
Participants will be enrolled during the preoperative evaluation, where their arterial pressure values, medical histories, and medication statuses will be recorded. Throughout the induction and maintenance of anesthesia, we will monitor their blood pressure values and document any instances of hypotension or hypertension. During the hemostatic phase, we will elevate the arterial pressure using noradrenaline by up to 10 mmHg above the recorded pressure measured at the inpatient clinic. Subsequently, we will inquire whether the neurosurgeon had to employ any additional hemostatic maneuvers following the increase in arterial pressure. The arterial pressure values will be recorded at the end of the surgery, and the first postoperative CT scan will be examined to identify any cases of intracranial hemorrhage.
Read the detailed description
During surgery to remove intracranial tumors, a patient's blood pressure is kept moderately low to facilitate the procedure. Subsequently, a surgical phase of hemostasis is performed. At this stage, the standard clinical practice requires the anesthesiologist to raise blood pressure to challenge the surgical hemostasis. Although this practice may be considered ubiquitous, it is not currently described in neuroanesthesia texts, and no studies are available that report the effect of this maneuver, either in terms of the optimal level of pressure elevation or in terms of the greater efficacy of a target of systolic arterial pressure (SAP) rather than mean arterial pressure (MAP). The most frequently sought increase in everyday clinical practice is about 10 mmHg higher than the first SAP measured in the patient's operating room. Because of the different profiles of brain autoregulation (Smith, 2015) and individual cardiovascular profiles, anticipatory and context anxiety accompanying the time of surgery, in line with the literature, the present study prefers to select the blood pressure value measured on the ward at the time of admission as the reference (Ackland et al., 2019; Ard \& Kendale, 2016). The study aims first to observe the effects on the operative field of this increase.
- Primary objective: To verify how frequently the SAP-increasing maneuver prompts the Neurosurgeon to perform a hemostatic maneuver on the surgical field and to evaluate whether the concomitant MAP value reached affects this frequency.
- Secondary objective: To quantify the frequency and severity of any postoperative intracranial hemorrhage in relation to the achieved MAP value.
There are no pharmacological strategies to increase SAP and MAP selectively. However, it can be estimated that the increase mentioned above in SAP, achieved in our institute with an intravenous norepinephrine infusion, is not accompanied by a parallel increase in MAP in about 50 percent of cases (unpublished data).
- Medical subject headings
- Intracranial Hemorrhages
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of need for hemostatic maneuver in the neurosurgical field
The investigators document the frequency with which the primary operators indicate the need for additional maneuvers once the target systolic arterial pressure (SAP) exceeds a 10 mmHg (millimetres of mercury ) increase from the baseline relative to the achieved mean arterial pressure (MAP) value.
Measured: During surgery
Number of postoperative neurosurgical site hemorrhage requiring treatment
In relation to the MAP value achieved, the investigators register the number of times the presence of a neurosurgical site hemorrhage calls for a novel surgical treatment or significant therapy adjustments.
Measured: In the 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start11 Nov 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeurosurgeryStudies of the same condition, open and under way.
- More trials run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaThe 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
- 160 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco Fabio Gemma, Dr, Principal investigator, Fondazione IRCCS Istituto Neurologico Carlo Besta Milan, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05874050
- Sponsor's protocol ID
- Ria2022_01
- Acronym
- HemoStopArt
- Status last verified
- Mar 2026
- First submitted
- 16 May 2023
- Last updated
- 30 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Arterial Pressure on Surgical Hemostasis During Elective Supratentorial Neurosurgery: a Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT05874050
- Acronym / sponsor ID
- HemoStopArt / Ria2022_01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaUniversity, hospital or other
- Study start
- 11 Nov 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 24 May 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.
The objective of this observational study is to examine the impact of augmented arterial pressure during the hemostatic phase of elective supratentorial neurosurgery. The primary inquiries it seeks to address are as follows:
- Does an increase in systolic arterial pressure prompt a hemostatic maneuver by the neurosurgeon, and does the concomitant mean arterial pressure value influence the frequency of such interventions?
- How often do postoperative intracranial hemorrhages occur, and how severe are they in relation to the achieved mean arterial pressure value?
Participants will be enrolled during the preoperative evaluation, where their arterial pressure values, medical histories, and medication statuses will be recorded. Throughout the induction and maintenance of anesthesia, we will monitor their blood pressure values and document any instances of hypotension or hypertension. During the hemostatic phase, we will elevate the arterial pressure using noradrenaline by up to 10 mmHg above the recorded pressure measured at the inpatient clinic. Subsequently, we will inquire whether the neurosurgeon had to employ any additional hemostatic maneuvers following the increase in arterial pressure. The arterial pressure values will be recorded at the end of the surgery, and the first postoperative CT scan will be examined to identify any cases of intracranial hemorrhage.
Detailed description
During surgery to remove intracranial tumors, a patient's blood pressure is kept moderately low to facilitate the procedure. Subsequently, a surgical phase of hemostasis is performed. At this stage, the standard clinical practice requires the anesthesiologist to raise blood pressure to challenge the surgical hemostasis. Although this practice may be considered ubiquitous, it is not currently described in neuroanesthesia texts, and no studies are available that report the effect of this maneuver, either in terms of the optimal level of pressure elevation or in terms of the greater efficacy of a target of systolic arterial pressure (SAP) rather than mean arterial pressure (MAP). The most frequently sought increase in everyday clinical practice is about 10 mmHg higher than the first SAP measured in the patient's operating room. Because of the different profiles of brain autoregulation (Smith, 2015) and individual cardiovascular profiles, anticipatory and context anxiety accompanying the time of surgery, in line with the literature, the present study prefers to select the blood pressure value measured on the ward at the time of admission as the reference (Ackland et al., 2019; Ard \& Kendale, 2016). The study aims first to observe the effects on the operative field of this increase.
- Primary objective: To verify how frequently the SAP-increasing maneuver prompts the Neurosurgeon to perform a hemostatic maneuver on the surgical field and to evaluate whether the concomitant MAP value reached affects this frequency.
- Secondary objective: To quantify the frequency and severity of any postoperative intracranial hemorrhage in relation to the achieved MAP value.
There are no pharmacological strategies to increase SAP and MAP selectively. However, it can be estimated that the increase mentioned above in SAP, achieved in our institute with an intravenous norepinephrine infusion, is not accompanied by a parallel increase in MAP in about 50 percent of cases (unpublished data).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive adult patients scheduled to undergo elective supratentorial neurosurgical surgery.
Key inclusion criteria (1 listed)
- All consecutive adult patients scheduled to undergo elective supratentorial neurosurgical surgery.
Key exclusion criteria (11 listed)
- Urgent or emergent surgery
- Neurovascular surgery
- Subtentorial surgery
- Trans nasal approaches
- Back surgery
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
Frequency of need for hemostatic maneuver in the neurosurgical field
Time frame: During surgery
The investigators document the frequency with which the primary operators indicate the need for additional maneuvers once the target systolic arterial pressure (SAP) exceeds a 10 mmHg (millimetres of mercury ) increase from the baseline relative to the achieved mean arterial pressure (MAP) value.
Number of postoperative neurosurgical site hemorrhage requiring treatment
Time frame: In the 24 hours after surgery
In relation to the MAP value achieved, the investigators register the number of times the presence of a neurosurgical site hemorrhage calls for a novel surgical treatment or significant therapy adjustments.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Marco Fabio Gemma, Dr principal investigator
Fondazione IRCCS Istituto Neurologico Carlo Besta Milan, Italy
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 Neurosurgery and Intracranial Hemorrhages, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta 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 1 inclusion and 11 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: finished, as of the sponsor's last update on 30 Mar 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of need for hemostatic maneuver in the neurosurgical field (time frame: During surgery). The study lists 2 primary outcomes in all. 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 30 Mar 2026.