The Effect of the Hemobag® Ultrafiltration System on Blood Conservation and Coagulation After Cardiopulmonary Bypass

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01435304
• Date of registration: 09/09/2011
• Primary sponsor: Maine Medical Center
• Public title: The Effect of the Hemobag® Ultrafiltration System on Blood Conservation and Coagulation After Cardiopulmonary Bypass
• Scientific title: The Effect of the Hemobag® Ultrafiltration System on Blood Conservation and Coagulation After Cardiopulmonary Bypass
• Date of first enrolment: September 2011
• Target sample size: 100
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01435304
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Countries of recruitment

United States

Contacts

• Name: Robert Kramer, MD

• Name: Robert Kramer, MD

• Name: Robert Kramer, MD
• Affiliation: Maine Medical Center

Key inclusion & exclusion criteria

Inclusion Criteria:

All adult cardiac surgery patients (age 18 or older) Cardiopulmonary bypass

Exclusion Criteria:

Patients under age 18 Off pump surgery



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Blood Coagulation Disorders

Intervention(s)

Device: method of returning residual CPB blood ( Hemobag®)

Primary Outcome(s)

Chest catheter drainage [Time Frame: Total amount for the first 24 hours postoperative]

Secondary Outcome(s)

Acute kidney injury (AKI) [Time Frame: All creatinines will be recorded and assessed during the entire index admission in order to compare postoperative to preoperative baseline creatinine, an expected average of 7 days.]

Blood products transfused (RBC's, platelets, FFP) [Time Frame: All blood products transfused during index admission, an expected average of 7 days, with the exception of preoperative transfusions.]

Mortality [Time Frame: 30 days postoperative]

Stroke [Time Frame: Index admission postoperative until the time of discharge, an expected average of 7 days.]

Vasoactive drugs [Time Frame: Any intravenous vasoactive drug being used at the 48 hour time point postoperative]

Secondary ID(s)

IRB # 3914

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Global Blood Resources, LLC