Bleeding
Conditions
Keywords
cardiac surgery requiring ECC
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),
Interventions
PROCEDUREcardiac surgery requiring ECC
the vacuum device is left on the 2 wounds (caused by the ECC cannulas) for 15 min (possible a second time of 15 min : 30 min max.)
Sponsors
AdministrateurCIC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Persistence or absence of bleeding extraMD at the orifice of the retrograde cannulation when the suction cup is in place. | 20-30 min |
Secondary
| Measure | Time frame |
|---|---|
| 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 at the orifice of the retrograde cannulation when the vacuum was removed. | 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 |
| Persistence or absence of bleeding at the orifice of the aortic purge when the vacuum was removed. | 20 -30 min |
Countries
France
Outcome results
None listed