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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 April 2016 |
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Main ID: |
NCT02367755 |
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Date of registration:
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02/02/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Therapeutic Hypothermia With Propofol in Survival and Neurological Prognoses After Cardiac Arrest
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Scientific title:
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Combining Propofol With Therapeutic Hypothermia for Improving Survival and Neurological Prognoses in Patients Resuscitated From Cardiac Arrest |
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Date of first enrolment:
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August 2013 |
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Target sample size:
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30 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02367755 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Yen-Wen Wu, MD, PhD |
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Address:
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Telephone:
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886-2-8966-7000 |
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Email:
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wuyw0502@gmail.com |
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Affiliation:
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Name:
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Yen-Wen Wu, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Far Eastern Memorial Hospital |
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Name:
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Yen-Wen Wu, MD, PhD |
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Address:
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Telephone:
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886-2-8966-7000 |
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Email:
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wuyw0502@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. non-traumatic cardiac arrest
2. no regain of consciousness after return of spontaneous circulation (ROSC)
3. age >=20 years old and <= 90 years old.
Exclusion criteria:
1. age < 20 y/o or > 90 y/o
2. pregnancy
3. traumatic cardiac arrest
4. fail to achieve ROSC
5. conscious recovery after ROSC
6. contraindications for TH, such as massive bleeding, infections, etc
7. terminal diseases
8. conscious disturbance before cardiac arrest
9. fail to obtain informed consent
10. families refuse to undergo clinical trial
11. allergy to propofol or lorazepam.
Age minimum:
20 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cardiac Arrest
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Hypothermia
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Intervention(s)
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Drug: Propofol
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Drug: Lorazepam
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Primary Outcome(s)
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Neurologic statue at discharge
[Time Frame: at dicharge]
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Secondary Outcome(s)
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From ROSC to recovery of consciousness
[Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks]
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Survival to discharge
[Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks]
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Brain SPECT The standard 99mTc-ethylene L-cysteinate dimer [ECD] will be done on day 5-14 post-resuscitation. The perfusion will be assessed, and the viability of the cerebral tissue will be interpreted using SPECT, by 2 experienced nuclear m
[Time Frame: day 5-14 post-resuscitation]
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Secondary ID(s)
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102060-F_102-FTN12
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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