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

Bleeding Clinical Trial

— HEMOCARD  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00843596
• Other study ID #: DCIC 0809
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 12, 2009
• Last updated: February 17, 2012
• Start date: October 2009
• Est. completion date: December 2011

Study information

• Verified date: February 2012
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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),

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bleeding

Intervention

Procedure:
• cardiac 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.)

Locations

Country	Name	City	State
France	UniversityHospitalGrenoble	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
AdministrateurCIC

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Persistence or absence of bleeding extraMD at the orifice of the retrograde cannulation when the suction cup is in place.		20-30 min	Yes
Secondary	Persistence or absence of bleeding intraMD at the orifice of the retrograde cannulation when the suction cup is in place.		20-30 min	Yes
Secondary	Persistence or absence of bleeding at the orifice of the retrograde cannulation when the vacuum was removed.		20-30 min	Yes
Secondary	Persistence or absence of bleeding extraMD at the orifice of the aortic purge when the suction cup is in place.		20- 30 min	Yes
Secondary	Persistence or absence of bleeding extraMD at the orifice of the aortic purge when the suction cup is in place.		20 -30 min	Yes
Secondary	Persistence or absence of bleeding at the orifice of the aortic purge when the vacuum was removed.		20 -30 min	Yes

External Links

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