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CompletedNCT00843596HEMOCARDUpdated Feb 20, 2012

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

A Phase 1/2 interventional study of cardiac surgery requiring ECC in Bleeding, sponsored by AdministrateurCIC. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-02-20.

Sponsored by AdministrateurCIC · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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),

02

Conditions studied

  • Bleeding

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Keywords

  • cardiac surgery requiring ECC
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    vacuum device - suction cup

    Procedure: cardiac surgery requiring ECC

Interventions

  • Procedurecardiac 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.)

05

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. 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

  2. Persistence or absence of bleeding at the orifice of the retrograde cannulation when the vacuum was removed.

    Time frame: 20-30 min

  3. 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

  4. 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

  5. Persistence or absence of bleeding at the orifice of the aortic purge when the vacuum was removed.

    Time frame: 20 -30 min

06

Study locations

1 site
  • UniversityHospitalGrenoble
    Grenoble, France
07

Registry details

Key details

Study ID
NCT00843596
Lead sponsor
AdministrateurCIC
Responsible party
AdministrateurCIC (principal investigator, University Hospital, Grenoble) — Sponsor-investigator
First posted
Feb 13, 2009
Start date
Oct 2009
Primary completion
Dec 2011
Completion
Dec 2011
Last update
Feb 20, 2012

Study contacts

Dominique BLIN, MD, PhD
principal investigator · University Hospital, Grenoble

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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