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

February 12, 2009
February 17, 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 ] [ Designated as safety issue: Yes ]
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 ] [ 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 ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00843596
DCIC 0809
Yes
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