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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AdministrateurCIC, University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00843596
First received: February 12, 2009
Last updated: February 17, 2012
Last verified: February 2012
History of Changes
  Purpose

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),


Condition Intervention Phase
Bleeding
 Procedure: cardiac surgery requiring ECC
 Phase 1
Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Persistence or absence of bleeding at the orifice of the retrograde cannulation when the vacuum was removed. [ Time Frame: 20-30 min ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Persistence or absence of bleeding at the orifice of the aortic purge when the vacuum was removed. [ Time Frame: 20 -30 min ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: October 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vacuum device - suction cup 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.)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00843596

Locations
France
UniversityHospitalGrenoble
Grenoble, France
Sponsors and Collaborators
AdministrateurCIC
Investigators
Principal Investigator: Dominique BLIN, MD, PhD University Hospital, Grenoble
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: AdministrateurCIC, principal investigator, University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT00843596     History of Changes
Other Study ID Numbers: DCIC 0809
Study First Received: February 12, 2009
Last Updated: February 17, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Grenoble:
cardiac surgery requiring ECC

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013