Arterial Pressure and Surgical Hemostasis in Elective Neurosurgery.

NCT05874050 | Completed

• 1 other identifier: Ria2022_01
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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. 1.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?
2. 2.How often do postoperative intracranial hemorrhages occur, and how severe are they in relation to the achieved mean arterial pressure value?

Conditions

Intracranial Hemorrhages; Supratentorial Brain Tumor; Blood Pressure; Neurosurgery

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  In the 24 hours after surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive adult patients scheduled to undergo elective supratentorial neurosurgical surgery.

You may qualify if:

• All consecutive adult patients scheduled to undergo elective supratentorial neurosurgical surgery.

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta: lead

Study Sites (1)

Fondazione IRCCS Istituto Neurologico C. Besta

Milan, Milano, 200133, Italy

Location

MeSH Terms

Conditions

Intracranial Hemorrhages

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marco Fabio Gemma, Dr

  Fondazione IRCCS Istituto Neurologico Carlo Besta Milan, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: May 24, 2023
• Study Start: November 11, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

IT (1)