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Completed

NCT Number: NCT00843596

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

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),

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Key information

Conditions

Bleeding Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

UniversityHospitalGrenoble

Grenoble, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cardiac surgery requiring ECC

Procedure

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 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

Sponsors and collaborators

Lead sponsor

AdministrateurCIC

Other

Registry information

Acronym: HEMOCARD

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Feb 13, 2009
Registry last updated
Feb 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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