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

February 17, 2012 updated by: AdministrateurCIC
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),

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France
        • UniversityHospitalGrenoble

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
20-30 min

Secondary Outcome Measures

Outcome Measure
Time Frame
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
20-30 min
Persistence or absence of bleeding at the orifice of the retrograde cannulation when the vacuum was removed.
Time Frame: 20-30 min
20-30 min
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
20- 30 min
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
20 -30 min
Persistence or absence of bleeding at the orifice of the aortic purge when the vacuum was removed.
Time Frame: 20 -30 min
20 -30 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdministrateurCIC

Investigators

  • Principal Investigator: Dominique BLIN, MD, PhD, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

February 12, 2009

First Submitted That Met QC Criteria

February 12, 2009

First Posted (Estimate)

February 13, 2009

Study Record Updates

Last Update Posted (Estimate)

February 20, 2012

Last Update Submitted That Met QC Criteria

February 17, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCIC 0809

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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