Reduction of Blood Recirculation in Veno-Venous ECMO
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Respiratory Distress Syndrome
- Extracorporeal Membrane Oxygenation
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Based on data from the 'Blood Recirculation and vvECMO' trial (ClinicalTrials.gov ID: NCT03200314) (i.e. an expected frequency of successful blood flow reduction of 66.7%), using a one-sample Chi square test, a two-sided type-1 error of 5%, a power of 80%, a total of 68 patients is needed to show th...
Based on data from the 'Blood Recirculation and vvECMO' trial (ClinicalTrials.gov ID: NCT03200314) (i.e. an expected frequency of successful blood flow reduction of 66.7%), using a one-sample Chi square test, a two-sided type-1 error of 5%, a power of 80%, a total of 68 patients is needed to show that the proportion of patients with a secure ECMO blood flow reduction is greater than 50%. Presumably, 136 Patients have to be included into the trial to study 68 patients with a relevant Rf since not all patients on V-V ECMO suffer from a high Rf.
Tracking Information
- NCT #
- NCT04754854
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Martin Russ, Dr. med. Charite University Hospital Berlin Principal Investigator: Philipp A Pickerodt, Dr. med. Charite University Hospital Berlin Principal Investigator: Vladimir Skrypnikov, Dr. med. Charite University Hospital Berlin Principal Investigator: Steffen Weber-Carstens, Prof. Dr. med. Charite University Hospital Berlin