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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00843596
First Posted: February 13, 2009
Last Update Posted: February 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AdministrateurCIC, University Hospital, Grenoble
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by AdministrateurCIC, 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 ]

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 ]
  • 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00843596


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

Responsible Party: AdministrateurCIC, principal investigator, University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT00843596     History of Changes
Other Study ID Numbers: DCIC 0809
First Submitted: February 12, 2009
First Posted: February 13, 2009
Last Update Posted: February 20, 2012
Last Verified: February 2012

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

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes