search
Back to results

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

Primary Purpose

Bleeding

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
cardiac surgery requiring ECC
Sponsored by
AdministrateurCIC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bleeding focused on measuring cardiac surgery requiring ECC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UniversityHospitalGrenoble

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

vacuum device - suction cup

Arm Description

Outcomes

Primary Outcome Measures

Persistence or absence of bleeding extraMD at the orifice of the retrograde cannulation when the suction cup is in place.

Secondary Outcome Measures

Persistence or absence of bleeding intraMD at the orifice of the retrograde cannulation when the suction cup is in place.
Persistence or absence of bleeding at the orifice of the retrograde cannulation when the vacuum was removed.
Persistence or absence of bleeding extraMD at the orifice of the aortic purge when the suction cup is in place.
Persistence or absence of bleeding extraMD at the orifice of the aortic purge when the suction cup is in place.
Persistence or absence of bleeding at the orifice of the aortic purge when the vacuum was removed.

Full Information

First Posted
February 12, 2009
Last Updated
February 17, 2012
Sponsor
AdministrateurCIC
search

1. Study Identification

Unique Protocol Identification Number
NCT00843596
Brief Title
Surgical Bleeding Control of Extra-corporeal Circulation (ECC) by Vacuum Devices
Acronym
HEMOCARD
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
AdministrateurCIC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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),

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding
Keywords
cardiac surgery requiring ECC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vacuum device - suction cup
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
cardiac surgery requiring ECC
Intervention Description
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.)
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
Persistence or absence of bleeding at the orifice of the retrograde cannulation when the vacuum was removed.
Time Frame
20-30 min
Title
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
Title
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
Title
Persistence or absence of bleeding at the orifice of the aortic purge when the vacuum was removed.
Time Frame
20 -30 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique BLIN, MD, PhD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
UniversityHospitalGrenoble
City
Grenoble
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs