Surgical Bleeding Control of Extra-corporeal Circulation (ECC) by Vacuum Devices

AdministrateurCIC30 enrolled

Overview

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),

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bleeding

Interventions

cardiac surgery requiring ECCPROCEDURE

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.)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

UniversityHospitalGrenoble

Grenoble, France

Outcomes

Primary Outcomes

Persistence or absence of bleeding extraMD at the orifice of the retrograde cannulation when the suction cup is in place.

Time frame: 20-30 min

Secondary Outcomes

Persistence or absence of bleeding intraMD at the orifice of the retrograde cannulation when the suction cup is in place.

Time frame: 20-30 min

Persistence or absence of bleeding at the orifice of the retrograde cannulation when the vacuum was removed.

Time frame: 20-30 min

Persistence or absence of bleeding extraMD at the orifice of the aortic purge when the suction cup is in place.

Time frame: 20- 30 min

Persistence or absence of bleeding extraMD at the orifice of the aortic purge when the suction cup is in place.

Time frame: 20 -30 min

Persistence or absence of bleeding at the orifice of the aortic purge when the vacuum was removed.

Time frame: 20 -30 min

Data from ClinicalTrials.gov

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