Surgical Bleeding Control of Extra-corporeal Circulation (ECC) by Vacuum Devices
HEMOCARD
1 other identifier
interventional
30
1 country
1
Brief 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),
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2009
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2009
CompletedFirst Posted
Study publicly available on registry
February 13, 2009
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedFebruary 20, 2012
February 1, 2012
2.2 years
February 12, 2009
February 17, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Persistence or absence of bleeding extraMD at the orifice of the retrograde cannulation when the suction cup is in place.
20-30 min
Secondary Outcomes (5)
Persistence or absence of bleeding intraMD at the orifice of the retrograde cannulation when the suction cup is in place.
20-30 min
Persistence or absence of bleeding at the orifice of the retrograde cannulation when the vacuum was removed.
20-30 min
Persistence or absence of bleeding extraMD at the orifice of the aortic purge when the suction cup is in place.
20- 30 min
Persistence or absence of bleeding extraMD at the orifice of the aortic purge when the suction cup is in place.
20 -30 min
Persistence or absence of bleeding at the orifice of the aortic purge when the vacuum was removed.
20 -30 min
Study Arms (1)
vacuum device - suction cup
EXPERIMENTALInterventions
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 Criteria
You may qualify if:
- more or equal than 18 years old
- patient affiliated to social security or similarly regime
- patient sent to hospital for cardiac surgery requiring ECC
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UniversityHospitalGrenoble
Grenoble, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dominique BLIN, MD, PhD
University Hospital, Grenoble
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
February 12, 2009
First Posted
February 13, 2009
Study Start
October 1, 2009
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
February 20, 2012
Record last verified: 2012-02