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

Phase 1

Completed

• Conditions: Bleeding
• Interventions: Procedure: cardiac surgery requiring ECC

• 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

Study Timeline

• Study First Submitted: 2009-02-12
• Study First Submitted QC: 2009-02-12
• Study First Posted: 2009-02-13
• Study Start: 2009-10
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-17
• Last Update Posted: 2012-02-20

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

Arm && Interventions

Group	Intervention	Description
vacuum device - suction cup	cardiac surgery requiring ECC	-

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 extraMD at the orifice of the aortic purge when the suction cup is in place.	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

Trial Locations

Locations (1)

UniversityHospitalGrenoble; 🇫🇷 Grenoble, France