Other Clinical Trial - Optimal Brain Oxygenation in Neurologic Intensive

Status Recruiting

Clinical Trial Summary

The NeurO2 study is a multicenter observational study looking at NIRS monitoring in neurocrocritically ill patients during the acute phase of care following an acute brain injury. The study is nested within the HEMOTION Trial and the SAHaRA Trial

Clinical Trial Description

The NeurO2 study is a multicenter prospective study nested within two large-scale pragmatic randomized open blinded endpoint (PROBE) trials in neurocritically ill patients, the HEMOTION and the SAHaRa trials. These two trials are designed to compare a restrictive and a liberal transfusion strategies in critically ill patients with traumatic brain injury or subarachnoid hemorrhage. The NeurO2 will report on prospectively gathered regional cerebral oxygenation data (rSO2) from enrolled patients randomized to either the liberal or restrictive RBC transfusion strategy of their parent trials. The primary outcome will be 6-month neurologic function based on the GOSe. The established infrastructure of the trials will be used, including part of the data collection instruments and the outcome assessment team. The NeurO2 study will achieve three separate but interconnected primary objectives: i) Evaluate if the cerebral hypoxemic burden as measured by NIRS during NICU stay, is associated with functional neurologic outcome (Glasgow Outcome Scale extended - GOSe) at 6 months, ii) Determine if the cerebral hypoxemic burden is impacted by red blood cell transfusion, iii) Determine if the level of response in cerebral hypoxemic burden after RBC transfusion is associated with the 6-month functional neurologic outcome (GOSe) The secondary objectives are to evaluate whether the cerebral hypoxemic burden measured by NIRS is associated with other clinically relevant outcomes including ICU, hospital and 6-month mortality and hospital, ICU length of stay and quality of life. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04935866
Study type	Observational
Source	CHU de Quebec-Universite Laval
Contact	Lucy Clayton, MSc
Phone	418-525-4444
Email	lucy.clayton.hsj@ssss.gouv.qc.ca
Status	Recruiting
Phase
Start date	May 7, 2021
Completion date	July 2025

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT00801931` - Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders	Phase 1/Phase 2
Completed	`NCT02948283` - Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia	Phase 1
Completed	`NCT03341338` - Genes-in-Action - Hepcidin Regulation of Iron Supplementation
Completed	`NCT00060398` - Epoetin Alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer	Phase 3
Recruiting	`NCT05384691` - Efficacy of Luspatercept in ESA-naive LR-MDS Patients With or Without Ring Sideroblasts Who do Not Require Transfusions	Phase 2
Not yet recruiting	`NCT06309641` - Methemoglobinemia Following Intravenous Iron Treatment
Completed	`NCT02912533` - A Long-term Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD)	Phase 3
Completed	`NCT02888171` - Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency	N/A
Completed	`NCT03822884` - Pharmacokinetic/Pharmacodynamic Study of 3 Subcutaneous Single Dose Epoetin Alfa Formulations in Healthy Volunteers	Phase 1
Completed	`NCT02912494` - A Phase III Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD)	Phase 3
Completed	`NCT02930850` - Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation	N/A
Completed	`NCT02384122` - Efficacy of Octreotide on Blood and Iron Requirements in Patients With Anemia Due to Angiodysplasias	Phase 3
Completed	`NCT02603250` - Evaluation of Hemoglobin Measurement Tools for Child Anemia Screening in Rwanda	N/A
Completed	`NCT02176759` - Iron Absorption From Rice Fortified With Ferric Pyrophosphate	N/A
Withdrawn	`NCT01934842` - A Study to Compare Analyte Levels in Blood Collected Using an Investigational Collection Device With a Commercial Predicate	N/A
Completed	`NCT02310113` - Transfusion and Skeletal Muscle Tissue Oxygenation	N/A
Completed	`NCT01922479` - Pilot Study of Ferric Carboxymaltose to Treat Iron Deficiency in Asians With Heart Failure	Phase 4
Completed	`NCT01693029` - Study to Compare Safety and Efficacy of HX575 Epoetin Alfa and US-licensed Epoetin Alfa	Phase 3
Completed	`NCT01432717` - Study of ACE-536 in Healthy Postmenopausal Women	Phase 1
Terminated	`NCT01535781` - Study of the Effect of Tranexamic Acid Administered to Patients With Hip Fractures. Can Blood Loss be Reduced?	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Optimal Brain Oxygenation in Neurologic Intensive Care Unit : The NeurO2 Study — NeurO2

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms