Clinical Trials Logo

Clinical Trial Summary

Introduction Patients with severe brain injury are often restricted to bed rest during the early period of brain injury which may lead to unwanted secondary complications. There is lack of evidence of when to initiate the first mobilisation. The Sara Combilizer® is an easy and efficient tool for mobilising patients with severe injuries, including brain injury. Through a randomised cross-over trial the investigators will investigate the impact of early mobilisation on patients with severe acquired brain injury caused by traumatic brain injury, subarachnoid brain injury or intracranial haematoma. The investigators hypothesise that mobilisation using the Sara Combilizer® does not affect partial oxygenation of brain tissue.


Clinical Trial Description

The primary purpose of this study is to quantify cerebral oxygenation, when mobilising patients with severe brain injury using a Sara Combilizer® to the seated position and during passive standing. This study is conducted at the Department of Neurointensive care and Neuroanaesthesiology, Rigshospitalet, Copenhagen. Based on the International Conference on harmonisation-Good Clinical Practice guidelines and the Danish "Good Clinical Practice" administrative order, a table regarding the responsibilities of sponsor/investigators before, during and after the clinical trial, will be filled and signed in order to avoid misunderstandings. This table can be found in the Trial Master File (TMF) located at the primary investigator's office and the sponsor's office. This study is designed as a cross-over study with patients randomly assigned to (1) an initial intervention protocol on the first day and with a passive sedentary protocol on the second, or (2) an initial passive sedentary protocol on the first day followed by an intervention protocol on the second day. Randomisation Included patients will, after stabilisation of ICP, be randomised to start with either the intervention or sedentary protocol, with the opposite protocol on the second day. A computer-generated randomisation algorithm will be created in REDCap, with age and Glasgow Coma Score (GCS) as dichotomised stratification variables. Age will be divided into young (18 to 60 years) and old (61+ years), and the GCS into severe brain injury (GCS 3-8) and moderate to mild injury (GCS 9-15). The following four composite groups of age and GCS will ensure an equal distribution of the patients within each stratum. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05038930
Study type Interventional
Source Rigshospitalet, Denmark
Contact Christian G Riberholt, Ph.D.
Phone +4522648823
Email christian.riberholt@regionh.dk
Status Recruiting
Phase N/A
Start date October 1, 2021
Completion date September 16, 2023

See also
  Status Clinical Trial Phase
Active, not recruiting NCT06043167 - Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
Recruiting NCT04189471 - Recovery After Cerebral Hemorrhage
Completed NCT03281590 - Stroke and Cerebrovascular Diseases Registry
Completed NCT05131295 - Dapsone Use in Patients With Aneurysmal Subarachnoid Hemorrhage. Phase 3
Recruiting NCT02962349 - TRansfusion Strategies in Acute Brain INjured Patients N/A
Completed NCT02872857 - Subarachnoid Hemorrhage Recovery And Galantamine Phase 1/Phase 2
Completed NCT03164434 - Influence of Drainage on EVD ICP-signal
Terminated NCT02216513 - Deferoxamine to Prevent Delayed Cerebral Ischemia After Subarachnoid Hemorrhage Phase 0
Completed NCT01077206 - High-dose Simvastatin for Aneurysmal Subarachnoid Haemorrhage Phase 2/Phase 3
Not yet recruiting NCT00905931 - Lycopene Following Aneurysmal Subarachnoid Haemorrhage Phase 2
Completed NCT02389634 - Identification of Novel Molecular Markers for Vasospasm
Completed NCT00962546 - Computed Tomographic (CT) Perfusion and CT Angiography as Screening Tools for Vasospasm Following Subarachnoid Hemorrhage N/A
Completed NCT01261091 - Early Tracheostomy in Ventilated Stroke Patients N/A
Completed NCT00507104 - Pituitary Functions After Traumatic Brain Injury (TBI) and/or Subarachnoid Hemorrhage (SAH)
Completed NCT00071565 - Familial Intracranial Aneurysm Study II N/A
Recruiting NCT05113381 - The Purpose of This Study is to Determine Whether CerebroFlo™ EVD Catheter is Effective During the Treatment of IVH N/A
Completed NCT04052646 - Prehospital Deaths From Spontaneous Subarachnoid Haemorrhages
Recruiting NCT04548596 - NOninVasive Intracranial prEssure From Transcranial doppLer Ultrasound Development of a Comprehensive Database of Multimodality Monitoring Signals for Brain-Injured Patients
Recruiting NCT06033378 - Blood Pressure Treatment in ICU Patients With Subarachniodal Haemorrhage. N/A
Completed NCT04308577 - Diet Induced Ketosis for Brain Injury - A Feasibility Study N/A