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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 July 31, 2014