Study for the Improvement of Long-Term Outcome Prediction in Patients in Coma After Cardiac Arrest

NCT02231060 | Completed DMC

• 1 other identifier: 2014_A55
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 16

Brief Summary

The primary objective of HOPE is to improve the accuracy of outcome prediction in anoxic-ischemic encephalopathy following cardiac arrest by bringing under close scrutiny some of the existing methods used for this purpose (e.g. somato-sensory evoked potentials). HOPE is the first multicenter prospective cohort study on coma prognosis to control for the effect of a possible self-fulfilling prophecy at the ICU and to cover the acute and neurorehabilitation phases with a long-term follow-up longer than the usual three or six months.

Conditions

Anoxic-Ischemic Encephalopathy

Keywords

Outcome Prediction; Anoxic-Ischemic Encephalopathy; Coma; Vegetative State; Minimally Conscious State; Chronic Disorders of Consciousness

Outcome Measures

Primary Outcomes (1)

• Current level of consciousness as measured by the revised version of the Coma Recovery Scale (CRS-R)

  The CRS-R allows a precise categorization of the current level of consciousness based on a structured and systematic clinical examination of auditory, visual, motor, oromotor, communication and arousal functions.

  There are 6 CRS-R data entry points distributed within a 12-month period, namely, 2 time points at the ICU, 3 time points during neurorehabilitation and 1 time point at the patient's residence 12 months after day 0.

Secondary Outcomes (1)

• Regaining of functional communication skills and optimal health-related quality of life

  Five data entry points distributed within a 12-month period, namely, 1 time point at the ICU, 3 time points during neurorehabilitation and 1 time point at the patient's residence 12 months after day 0.

Study Arms (1)

AIE after Cardiac Arrest

Male and female patients with AIE following CA.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with anoxic-ischemic encephalopathy following cardiac arrest.

You may qualify if:

• Age between 18 and 85 years
• Cause of admission to ICU: cardiac arrest (in or out of hospital)
• Glasgow-Coma-Scale \< 9 at time of study enrolment (3 to 8 days after cardiac arrest)
• Informed consent signed by legal guardian/next-of-kin

You may not qualify if:

• Stroke (as it may interfere with SSEP testing)
• Pre-existing coma/vegetative state/minimally conscious state
• Terminal malignant disease
• Survival in the next 12 months extremely unlikely
• Existing advanced directive that demands cessation of therapy/life support
• Palliative care/withdrawal of life support during treatment at the ICU
• Barbiturate-induced general anesthesia during the first 3 days after cardiac arrest
• Impossibility of assessing current level of consciousness with the Glasgow Coma Scale due to a long-term deep sedation

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead
• Else Kröner Fresenius Foundation: collaborator
• University Hospital Augsburg: collaborator
• Klinikum Ingolstadt: collaborator
• Klinikum Rosenheim: collaborator
• Therapiezentrum Burgau: collaborator
• Schoen Clinic Bad Aibling: collaborator
• Schön Klinik München Schwabing: collaborator
• Asklepios Stadtklinik Bad Tölz: collaborator
• Technical University of Munich: collaborator
• Krankenhaus Barmherzige Brüder München: collaborator
• Roteskreuzklinikum München: collaborator
• Deutsches Herzzentrum Muenchen: collaborator

Study Sites (16)

Department of Neurology, Klinikum Augsburg

Augsburg, Bavaria, 86009, Germany

Location

I. Medizinische Klinik, Klinikum Augsburg

Augsburg, Bavaria, 86009, Germany

Location

Schön Klinik Bad Aibling

Bad Aibling, Bavaria, 83043, Germany

Location

Dept of Neurology, Asklepios Stadtklinik Bad Tölz

Bad Tölz, Bavaria, 83646, Germany

Location

Therapiezentrum Burgau

Burgau, Bavaria, 89331, Germany

Location

Medizinische Klinik I und IV, Klinikum Ingolstadt

Ingolstadt, Bavaria, 85021, Germany

Location

Neurologische Klinik, Klinikum Ingolstadt

Ingolstadt, Bavaria, 85021, Germany

Location

Deutsches Herzzentrum Muenchen

Munich, Bavaria, 80636, Germany

Location

Krankenhaus Barmherzige Brüder München

Munich, Bavaria, 80639, Germany

Location

Schön Klinik München Schwabing

Munich, Bavaria, 80804, Germany

Location

Department of Neurology, University of Munich

Munich, Bavaria, 81377, Germany

Location

Internal ICU, Medical Clinic and Polyclinic IV, University of Munich

Munich, Bavaria, 81377, Germany

Location

Medizinische Klinik und Poliklinik I, University of Munich

Munich, Bavaria, 81377, Germany

Location

Department of Neurology

Munich, Bavaria, 81675, Germany

Location

Clinic for Anesthesiology, University of Munich

Munich, Bavaria, D-81377, Germany

Location

Neurologische Klinik, RoMed Klinikum Rosenheim

Rosenheim, Bavaria, 83022, Germany

Location

Related Publications (1)

• Lopez-Rolon A, Bender A; Project HOPE Investigator Group. Hypoxia and Outcome Prediction in Early-Stage Coma (Project HOPE): an observational prospective cohort study. BMC Neurol. 2015 May 15;15:82. doi: 10.1186/s12883-015-0337-x.

  PMID: 25971341 BACKGROUND

Related Links

• Hypoxia and Outcome Prediction in Early-Stage Coma (Project HOPE): an observational prospective cohort study

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain; Coma; Persistent Vegetative State

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Brain Damage, Chronic

Study Officials

• Andreas Bender, MD

  Ludwig-Maximilians-Universität München

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Doctor Medicinae (Prof. Dr. med.)

Study Record Dates

• First Submitted: August 29, 2014
• First Posted: September 3, 2014
• Study Start: October 1, 2014
• Primary Completion: December 6, 2018
• Study Completion: December 6, 2018
• Last Updated: December 12, 2018

Record last verified: 2018-12

Locations

DE (16)