ClinicalTrials.gg
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

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

Where this study stands

Counted across the records on this site · 2026-11-14

Among 120 studies in Hemorrhage with a site in France — 25 open to participants now, 31 under way, 4 of them phase 3. Hemorrhage · France.

Enrollment
63rd of 74
30 · median 150
Started
2009
with 6 others
Phase 1/2
2 of 120
none open now
Registered
14th of 120
by date

Among the 120 studies in Hemorrhage with a site in France, this one is the 63rd largest by enrollment of the 74 interventional ones that give a count, is one of 7 that started in 2009, is one of 2 in phase 1/2, and was the 14th registered.

Hemorrhage

1,384 studies on the registry are indexed under Hemorrhage; 245 are open to participants now.

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Open to participants now

25 of the 120 studies in Hemorrhage with a site in France are open now. Recruiting first, the newest first:

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All 25 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 171 Hemorrhage studies recruiting now, 109 (64%) set no upper age limit and 41 (24%) stop at 75 or younger; 26 take children under 18; 21 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

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),

03

Conditions studied

  • Bleeding

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Keywords

  • cardiac surgery requiring ECC
04

Who can participate

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

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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
05

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.)

06

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

07

Study locations

1 site
  • UniversityHospitalGrenoble
    Grenoble, France
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2009, a primary completion of Dec 2011 and a completion of Dec 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 12, 2009
First posted
Feb 13, 2009
Start
Oct 2009
Primary completionActual
Dec 2011
CompletionActual
Dec 2011
Last update
Feb 20, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 20, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

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 ↗

Not currently enrolling

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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Discussion

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