The Investigation of the Impact of Early Mobilization on the Outcome in Patients With Aneurysmal Subarachnoid Hemorrhage.

NCT06436508 | Recruiting

• 1 other identifier: HunSAHEMob
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of the randomized clinical trial is to examine the effect of early mobilization on primary and secondary outcomes in patients with subarachnoid hemorrhage caused by aneurysm rupture. Researchers will compare early mobiliziation vs. standrad bed rest care.

Conditions

Early Ambulation; Standard of Care; Subarachnoid Hemorrhage, Aneurysmal

Keywords

subarachnoid hemorrhage; early mobilization

Outcome Measures

Primary Outcomes (2)

• Disability in early mobilization group (EM) vs. standard care group (SC) - modified Rankin score

  Outcome assessments will include: Modified Rankin Scale Disability is assessed by the modified Rankin Scale, dichotomized at a score of 0 to 3 versus 4 to 6 (6=death).Assessment is performed by a blinded investigator of the local study center by personal visit.

  14 day; 3 months

• Disability in early mobilization group (EM) vs. standard care group (SC) - Extended Glasgow Outcome Scale

  Extended Glasgow Outcome Scale Description of the neurological outcome by using extended Glasgow Outcome Score 1. Death 2. Vegetative sate 3. Lower severe disability 4. Upper severe disability 5. Lower moderate disability 6. Upper moderate disability 7. Lower good recovery 8. Upper good recovery Assessment is performed by a blinded investigator of the local study center by personal visit.

  14 day; 3 months

Secondary Outcomes (10)

• Onset of delayed cerebral ischemia (DCI)

  3-21 days

• Onset of severity of macrovascular vasospasm

  Up to 14 days

• Stay in the Intensive Care Unit (ICU)

  Up to 28 days

• Type of post-hospital discharge placement

  Up to 30 days

• Readmission to the ICU

  Up to 30 days

Study Arms (2)

Early mobilization

EXPERIMENTAL

This group is mobilized in the intensive care unit by the institutional physiotherapist with the assistance of specialized personnel. Mobilization is carried out according to the Early Mobilization Protocol (EMP) Early mobilization protocol: * Step 1 - Day 1: Bed rest, elevation of the head end to 30° * Step 2 - Day 2: Bed rest, elevation of the head end to 60° * Step 3 - Day 3: Bed rest, elevation of the head end to 80° * Step 4 - Day 4: Sitting on the edge of the bed * Step 5 - Day 5: Sitting in a chair, standing up * Step 6 - Day 6: Walking with or without assistance * Step 7 - Day 7: Walking with or without assistance from today

Behavioral: Early mobilization protocol

Standard bed rest

ACTIVE COMPARATOR

No early mobilization

Behavioral: Standard care

Interventions

Early mobilization protocol BEHAVIORAL

* Step 1 - Day 1: Bed rest, elevation of the head end to 30° * Step 2 - Day 2: Bed rest, elevation of the head end to 60° * Step 3 - Day 3: Bed rest, elevation of the head end to 80° * Step 4 - Day 4: Sitting on the edge of the bed * Step 5 - Day 5: Sitting in a chair, standing up * Step 6 - Day 6: Walking with or without assistance * Step 7 - Day 7: Walking with or without assistance from today

Early mobilization

Standard care BEHAVIORAL

During standard care, early mobilization does not take place in the intensive care unit; the patient receives only standard supportive care in bed rest.

Standard bed rest

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 ys
• Premorbid modified Rankin Scale score of 0-2
• WFNS I-IV at enrollment
• Aneurysm occlusion has occurred through open or endovascular means
• Minimum 24 hours elapsed after aneurysm occlusion
• The patient has not received thrombolytic therapy
• Vital parameters are appropriate (mean arterial pressure \[MAP\] \>80 or \>110 mm Hg)
• Signed patient information and consent form
• Enrollment occurs within 72 hours following ictus

You may not qualify if:

• Age under 18 years
• Traumatic subarachnoid hemorrhage
• Incapacitated or limited capacity for action before ictus
• Confirmed pregnancy
• Aneurysm multiplicity (unless all aneurysms are treated)

Sponsors & Collaborators

• University of Pecs: lead
• National Institute of Mental, Neurological and Neurosurgery: collaborator
• Borsod-Abaúj-Zemplén County Central Hospital and University Teaching Hospital: collaborator

Study Sites (3)

University of Pecs

Pécs, Baranya, 7624, Hungary

RECRUITING

Central Hospital of B.A.Z. County

Miskolc, BAZ, 3526, Hungary

RECRUITING

National Institute of Mental Health, Neurology, and Neurosurgery

Budapest, 1145, Hungary

RECRUITING

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Peter Csecsei, MD. PhD

  University of Pecs

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Csecsei, MD. PhD

CONTACT

+0672535900; csecsei.peter@pte.hu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: May 31, 2024
• Study Start: June 14, 2023
• Primary Completion: January 31, 2025
• Study Completion: March 31, 2026
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After study completion for 3 years.
• Access Criteria: upon reasonable request

Locations

HU (3)