The Effect of the Hemobag® Ultrafiltration System on Blood Conservation and Coagulation After Cardiopulmonary Bypass
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01435304|
Recruitment Status : Completed
First Posted : September 16, 2011
Last Update Posted : March 24, 2016
|Condition or disease||Intervention/treatment||Phase|
|Blood Coagulation Disorders||Device: method of returning residual CPB blood ( Hemobag®)||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of the Hemobag® Ultrafiltration System on Blood Conservation and Coagulation After Cardiopulmonary Bypass|
|Study Start Date :||September 2011|
|Primary Completion Date :||December 2014|
|Study Completion Date :||December 2014|
Hemobag® method of returning residual CPB blood (study group)
Device: method of returning residual CPB blood ( Hemobag®)
The Hemobag® is a collection reservoir used to facilitate ultrafiltration of the CPB circuit after the patient has been disconnected from CPB).
Other Name: Hemobag®
No Intervention: cell saver
Standard method of returning the residual pump volume to the patient as washed, centrifuged cells (control group)
- Chest catheter drainage [ Time Frame: Total amount for the first 24 hours postoperative ]Chest catheters are placed in the mediastinum and sometimes pleural space(s) to collect shed mediastinal blood in the first 24 hours post operative cardiac surgery
- 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. ]These blood components can be a metric of the success of achieving a satisfactory coagulation status.
- 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. ]Using the AKIN definition (Acute Kidney Injury Network), serial postoperative creatinines will reflect the presence of AKI when compared with the baseline creatinine.
- Mortality [ Time Frame: 30 days postoperative ]Patients will be followed for 30 days post operative
- Stroke [ Time Frame: Index admission postoperative until the time of discharge, an expected average of 7 days. ]Any neurological defect according to Society of Thoracic Surgery (STS) definition
- Vasoactive drugs [ Time Frame: Any intravenous vasoactive drug being used at the 48 hour time point postoperative ]This metric is a surrogate for low output failure and /or vasoplegia depending upon whether inotropes or vasoconstrictors are used.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01435304
|United States, Maine|
|Maine Medical Center|
|Portland, Maine, United States, 04102|
|Principal Investigator:||Robert Kramer, MD||Maine Medical Center|