Trial Outcomes & Findings for The Effect of the Hemobag® Ultrafiltration System on Blood Conservation and Coagulation After Cardiopulmonary Bypass (NCT NCT01435304)

NCT ID: NCT01435304

Last Updated: 2018-06-06

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 100 participants
• Primary outcome timeframe: Total amount for the first 24 hours postoperative
• Results posted on: 2018-06-06

Participant Flow

Participant milestones

Measure	Hemobag® Hemobag® method of returning residual CPB blood (study group) 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).	Cell Saver Standard method of returning the residual pump volume to the patient as washed, centrifuged cells (control group)
Overall Study STARTED	50	50
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Hemobag® n=50 Participants Hemobag® method of returning residual CPB blood (study group) 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).	Cell Saver n=50 Participants Standard method of returning the residual pump volume to the patient as washed, centrifuged cells (control group)	Total n=100 Participants Total of all reporting groups
Age, Continuous	64.4 years STANDARD_DEVIATION 10.5 • n=5 Participants	63.3 years STANDARD_DEVIATION 15.3 • n=7 Participants	63.8 years STANDARD_DEVIATION 13.1 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	7 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants	43 Participants n=7 Participants	78 Participants n=5 Participants
Region of Enrollment United States	50 Participants n=5 Participants	50 Participants n=7 Participants	100 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Hemobag® n=50 Participants Hemobag® method of returning residual CPB blood (study group) 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).	Cell Saver n=50 Participants Standard method of returning the residual pump volume to the patient as washed, centrifuged cells (control group)
Amount of Chest Catheter Drainage 24 Hours Postoperatively	766 mL Standard Deviation 845	626 mL Standard Deviation 427

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Hemobag® n=50 Participants Hemobag® method of returning residual CPB blood (study group) 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).	Cell Saver n=50 Participants Standard method of returning the residual pump volume to the patient as washed, centrifuged cells (control group)
Number of Participants Which Had Blood Products Transfused (RBC's, Platelets, FFP)	8 Participants	6 Participants

SECONDARY outcome

Timeframe: 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 Acute Kidney Injury Network (AKIN) definition of a 0.03mg/dL increase in serum creatinine within 48 hours of surgery, serial postoperative creatinines will reflect the presence of AKI when compared with the baseline creatinine.

Outcome measures

Measure	Hemobag® n=50 Participants Hemobag® method of returning residual CPB blood (study group) 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).	Cell Saver n=50 Participants Standard method of returning the residual pump volume to the patient as washed, centrifuged cells (control group)
Number of Participants With Acute Kidney Injury (AKI)	6 Participants	6 Participants

SECONDARY outcome

Timeframe: Index admission postoperative until the time of discharge, an expected average of 7 days.

Patients will be followed until hospital discharge

Outcome measures

Measure	Hemobag® n=50 Participants Hemobag® method of returning residual CPB blood (study group) 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).	Cell Saver n=50 Participants Standard method of returning the residual pump volume to the patient as washed, centrifuged cells (control group)
Number of Participants With a Mortality	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Hemobag® n=50 Participants Hemobag® method of returning residual CPB blood (study group) 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).	Cell Saver n=50 Participants Standard method of returning the residual pump volume to the patient as washed, centrifuged cells (control group)
Number of Participants With Stroke	0 Participants	2 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Hemobag® n=50 Participants Hemobag® method of returning residual CPB blood (study group) 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).	Cell Saver n=50 Participants Standard method of returning the residual pump volume to the patient as washed, centrifuged cells (control group)
Number of Participants on Vasoactive Drugs at 48 Hours Post op Point	12 Participants	14 Participants

Adverse Events

Hemobag®

Serious events: 0 serious events

Other events: 12 other events

Deaths: 2 deaths

Cell Saver

Serious events: 2 serious events

Other events: 14 other events

Deaths: 1 deaths

Serious adverse events

Measure	Hemobag® n=50 participants at risk Hemobag® method of returning residual CPB blood (study group) 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).	Cell Saver n=50 participants at risk Standard method of returning the residual pump volume to the patient as washed, centrifuged cells (control group)
Nervous system disorders Stroke	0.00% 0/50	4.0% 2/50 • Number of events 2

Other adverse events

Measure	Hemobag® n=50 participants at risk Hemobag® method of returning residual CPB blood (study group) 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).	Cell Saver n=50 participants at risk Standard method of returning the residual pump volume to the patient as washed, centrifuged cells (control group)
Cardiac disorders Low output failure	24.0% 12/50 • Number of events 12	28.0% 14/50 • Number of events 14

Additional Information

Dr. Robert S Kramer

Maine Medical Center

Phone: 207-662-1486

Email: Kramer@mmc.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place