N/A
N=100
The Effect of the Hemobag® Ultrafiltration System on Blood Conservation and Coagulation After Cardiopulmonary Bypass
Blood Coagulation Disorders
Bottom Line
View on ClinicalTrials.gov: NCT01435304 ↗Enrolled (actual)
100
Serious AEs
2.0%
Results posted
May 2018
Primary outcome: Primary: Amount of Chest Catheter Drainage 24 Hours Postoperatively — 766; 626 mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- method of returning residual CPB blood ( Hemobag®) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- MaineHealth
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Amount of Chest Catheter Drainage 24 Hours Postoperatively |
766; 626 | — |
| SECONDARY Number of Participants Which Had Blood Products Transfused (RBC's, Platelets, FFP) |
8; 6 | — |
| SECONDARY Number of Participants With Acute Kidney Injury (AKI) |
6; 6 | — |
| SECONDARY Number of Participants With a Mortality |
2; 1 | — |
| SECONDARY Number of Participants With Stroke |
0; 2 | — |
| SECONDARY Number of Participants on Vasoactive Drugs at 48 Hours Post op Point |
12; 14 | — |
Summary
This proposal is designed to mitigate hemodilution (blood diluted with an electrolyte solution) and loss of plasma proteins responsible for normal blood clotting as well as platelets at the completion of cardiopulmonary bypass (CPB). The Hemobag® system is a device qualified by the US Food and Drug Administration (FDA). Many cardiac centers, such as Englewood Hospital and Medical Center in Englewood NJ are using the Hemobag® system for Jehovah's witnesses and other patients who go to that center for bloodless cardiac surgery (cardiac surgery performed without the use of blood or blood products). The system is designed to filter excessive water from blood left in the heart lung machine (cardiopulmonary bypass) after it is separated from the patient during the performance of cardiac surgery. Consequently the likelihood of excessive post-operative bleeding and transfusion with allogeneic blood (blood bank blood from donors) is decreased.
Eligibility Criteria
Inclusion Criteria
All adult cardiac surgery patients (age 18 or older) Cardiopulmonary bypass
Exclusion Criteria
Patients under age 18 Off pump surgery
Data sourced from ClinicalTrials.gov (NCT01435304). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.