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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06299969
Other study ID # StBernwardH
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2023
Est. completion date December 31, 2025

Study information

Verified date March 2024
Source St.Bernward Hospital
Contact Karl H Scholz, MD
Phone +4955139
Email k.scholz@fitt-stemi.de
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The trial collects and analyzes data from Cardiac Arrest Centres in patients with out-of-hospital cardiac arrest (OHCA).


Description:

With around 70,000 cases per year, out-of-hospital cardiac arrest (OHCA) is one of the most common causes of death in Germany. Only less than 10% of patients with an OHCA can currently be discharged with a satisfactory neurological outcome. The FITT-OHCA trial is a quality management project and collects data from Cardiac Arrest Centres on pre-hospital care and early post-resuscitation treatment in a standardized manner. The aim is to optimize the treatment process in patients following successful prehospital resuscitation through systematic data collection and feedback to the members of the rescue and treatment chain. The study includes cluster randomization of the participating hospitals.


Recruitment information / eligibility

Status Recruiting
Enrollment 3000
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients after cardiac arrest Exclusion Criteria: - refused register participation by patient or legal representative

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany St Bernward Hospital Hildesheim Niedersachsen

Sponsors (2)

Lead Sponsor Collaborator
St.Bernward Hospital University Medical Center Goettingen

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary In-hospital mortality Death/Survival at discharge 3 weeks
Secondary CPC score Cerebral performance category 3 weeks
Secondary MRS Modified ranking scale 3 weeks
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