Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02292147
Other study ID # P111012
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 13, 2013
Est. completion date October 20, 2017

Study information

Verified date November 2017
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Descriptive and prognosis study of the functional outcome after cardiac arrest for the patients awake within the first 15 days.


Description:

Functional outcome after cerebral anoxia due to cardiac arrest is poorly documented.. Survival after out of hospital cardiac arrest has improved and long term follow up of the patients is not routinely effective. Patients showing sign of awakening very early are considered in a good outcome group. Nevertheless they can experience some restriction and difficulties when they try to return to their premorbid level of functioning.

We aim to study their long term functional outcome and their level of anxiety, depression, quality of life and caregiver burden as well as their general cognitive functioning. Prognosis factors will be studied in the acute phase.


Recruitment information / eligibility

Status Completed
Enrollment 140
Est. completion date October 20, 2017
Est. primary completion date October 20, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion criteria :

- age 18 to 85

- Out of hospital cardiac arrest ; cardiac arrest in the ER is eligible

- Glasgow Coma Score = 12 within 15 days after onset

- Living in the parisian area

Exclusion criteria :

- no social security

- Neurological condition (multiple sclerosis, parkinson disease, AMS, stroke) priori to the cardiac arrest

- Psychiatric condition (schizophrenia, severe bipolar syndrome, long term neuroleptic medication, autistic spectrum disorders

- Deafness and blindness

- Neoplasia

- Premorbid limitation of autonomy.

- Difficulties in speaking and writing the French language

Study Design


Locations

Country Name City State
France Pitié salpetriere Hospital Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

Peskine A, Cariou A, Hajage D, Deye N, Guérot E, Dres M, Sonneville R, Lafourcade A, Navarro V, Robert H, Azouvi P, Sharshar T, Bayen E, Luyt CE; Hanox Study Group. Long-term disabilities of survivors of out-of-hospital cardiac arrest: the Hanox study. Ch — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Glasgow outcome Scale Extended score Functional outcome at 18 months 18 months
See also
  Status Clinical Trial Phase
Recruiting NCT02934867 - Out of Hospital Cardiac Arrest: Trial Assessing the Survival Impact of Phone Advice N/A
Completed NCT02236819 - A Multi-centre Survey of Epidemiology, Treatment and Outcome of Patients Suffering an Out-of-hospital Cardiac Arrest
Completed NCT03743584 - Hypothermia After Cardiac Arrest - Effects on Myocardial Function and Inflammatory Response. N/A
Recruiting NCT06153160 - "The Effect of the Use of an Autotransfusion Device on Hemodynamic Parameters During Resuscitation". N/A
Not yet recruiting NCT06177730 - Pre-hospital ECMO or Conventional Resuscitation for Refractory Cardiac Arrest N/A
Completed NCT02010151 - Dispatcher-Activated Neighborhood Access Defibrillation and Cardiopulmonary Resuscitation N/A
Not yet recruiting NCT05185063 - Developing a Digital Handover Application for Paramedics to Provide a Personalized Approach to Pre-hospital Stratification for Out of Hospital Cardiac Arrest
Completed NCT01372748 - Continuous Chest Compressions vs AHA Standard CPR of 30:2 Phase 4
Completed NCT01818388 - COOL-ARREST Pilot Study to Assess Intravascular Temperature Management (IVTM) in the Treatment of Cardiac Arrest
Completed NCT01528475 - Initiation of Cooling by EMS to Promote Adoption of In-hospital Hypothermia in Cardiac Arrest Survivors N/A
Terminated NCT04431661 - CAOCT: Intra CoronAry Optical Computerized Tomography in out-of Hospital Cardiac Arrest Patients
Completed NCT02142387 - Effects of a New Dispatcher-Assisted Basic Life Support Training Program N/A
Completed NCT01689077 - Time-differentiated Therapeutic Hypothermia N/A
Unknown status NCT02007499 - Pre-arrival Instructions Effect on Bystander Cardiopulmonary Resuscitation (CPR). N/A
Completed NCT02401633 - Compression Only-CPR Versus Standard-CPR N/A
Terminated NCT02090218 - I-Gel in Out-of-hospital Cardiac Arrest in Norway N/A
Completed NCT03065946 - Therapeutic Hypothermia and eArly Waking
Not yet recruiting NCT02587494 - Cardiac Catheterization in Cardiac Arrest N/A
Recruiting NCT02637258 - Can Optic Nerve Sheath Diameter Measurement Predict Negative Neurological Outcome ? N/A
Completed NCT03312296 - Definite Stent Thrombosis in Comatose Out of Hospital Cardiac Arrest Survivors