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

AdministrateurCIC

Status and phase: Completed; Phase 2; Phase 1

Conditions: Bleeding

Treatments: Procedure: cardiac surgery requiring ECC

Study type: Interventional

Funder types: Other

Identifiers

NCT00843596

DCIC 0809

Details and patient eligibility

About

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),

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

vacuum device - suction cup

Experimental group

Treatment:

Procedure: cardiac surgery requiring ECC