Surgical Bleeding Control of Extra-corporeal Circulation (ECC) by Vacuum Devices
Phase 1
Completed
- Conditions
- Bleeding
- Registration Number
- NCT00843596
- Lead Sponsor
- AdministrateurCIC
- Brief Summary
the purpose of this study is to show that the vacuum control surgical bleeding helps stop bleeding extraMD (MD: Medical Device) at the orifice of the retrograde cannulation during a heart with Extra-corporeal circulation (ECC),
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- more or equal than 18 years old
- patient affiliated to social security or similarly regime
- patient sent to hospital for cardiac surgery requiring ECC
Exclusion Criteria
- Pregnant women and lactating mothers
- Ward of court or under guardianship
- Adult unable to express their consent
- Person deprived of freedom by judicial or administrative decision
- Person hospitalized without their consent
- Person under legal protection
- Person participating in another clinical study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Persistence or absence of bleeding extraMD at the orifice of the retrograde cannulation when the suction cup is in place. 20-30 min
- Secondary Outcome Measures
Name Time Method Persistence or absence of bleeding at the orifice of the retrograde cannulation when the vacuum was removed. 20-30 min Persistence or absence of bleeding at the orifice of the aortic purge when the vacuum was removed. 20 -30 min Persistence or absence of bleeding intraMD at the orifice of the retrograde cannulation when the suction cup is in place. 20-30 min Persistence or absence of bleeding extraMD at the orifice of the aortic purge when the suction cup is in place. 20 -30 min
Trial Locations
- Locations (1)
UniversityHospitalGrenoble
🇫🇷Grenoble, France
UniversityHospitalGrenoble🇫🇷Grenoble, France