Ventricular FibrillationINCANCT00520520
Influence of Mild Therapeutic Hypothermia on Leukocyte Count
An observational study of Ventricular Fibrillation, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Mild therapeutic hypothermia is indicated in patients surviving out-of-hospital cardiac arrest due to ventricular fibrillation. Potential immunologic responses are unknown. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Ventricular Fibrillation
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Dec 2009to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
Study population: Survivors in out of hospital cardiac arrest
Who may be able to join
- Survivors of cardiac arrest due to VF
- Age 18-90
Who cannot join
- Suspected / proven pregnancy
- Immunodeficiency
Trial locations and contacts
1 site in 1 country.
About this study
Mild therapeutic hypothermia is indicated in patients surviving out-of-hospital cardiac arrest due to ventricular fibrillation. Potential immunologic responses are unknown.
- Conditions
- Ventricular Fibrillation
- Keywords
- post resuscitation, post ventricular fibrillation, patients receiving mild therapeutic hypothermia
- Medical subject headings
- Ventricular Fibrillation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2007 (estimated)
- Study startDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular FibrillationStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Investigators
- Joerg C Schefold, MD, Principal investigator, Charite University, Berlin, GermanyChristian Storm, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00520520
- Sponsor's protocol ID
- I-STU-26
- Acronym
- INCA
- Status last verified
- Jul 2009
- First submitted
- 22 Aug 2007
- Last updated
- 4 Aug 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Mild Therapeutic Hypothermia on Leukocyte Count
- ClinicalTrials.gov ID
- NCT00520520
- Acronym / sponsor ID
- INCA / I-STU-26
- Conditions
- Ventricular Fibrillation
- Keywords
- post resuscitation, post ventricular fibrillation, patients receiving mild therapeutic hypothermia
- Study type
- Observational
- Recruitment status
- Terminated
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Dec 2009
- First posted
- 24 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mild therapeutic hypothermia is indicated in patients surviving out-of-hospital cardiac arrest due to ventricular fibrillation. Potential immunologic responses are unknown.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Survivors in out of hospital cardiac arrest
Key inclusion criteria (2 listed)
- Survivors of cardiac arrest due to VF
- Age 18-90
Key exclusion criteria (2 listed)
- Suspected / proven pregnancy
- Immunodeficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2015.
Related trials for Ventricular Fibrillation
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
RecruitingObservational study
AI-Based Cardiac Analysis Using 12-Lead and 1-Lead ECG
Heart Failure, Atrial Fibrillation (AF)
RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
Recruiting
Bundle Branch Pacing to Preserve Ejection Fraction in Atrial Fibrillation Trial
Permanent Atrial Fibrillation, Preserved Ejection Fraction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joerg C Schefold, MD principal investigator
Charite University, Berlin, Germany
Christian Storm, MD principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Fibrillation, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2015.