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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
February 12, 2009
February 13, 2009
February 20, 2012
October 2009
December 2011   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00843596 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Surgical Bleeding Control of Extra-corporeal Circulation (ECC) by Vacuum Devices
Not Provided
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),
Not Provided
Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Bleeding
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.)
Experimental: vacuum device - suction cup
Intervention: Procedure: cardiac surgery requiring ECC
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 2011
December 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00843596
DCIC 0809
Yes
Not Provided
Not Provided
AdministrateurCIC, University Hospital, Grenoble
AdministrateurCIC
Not Provided
Principal Investigator: Dominique BLIN, MD, PhD University Hospital, Grenoble
University Hospital, Grenoble
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP