Trial Outcomes & Findings for A Randomized Multicenter Clinical Study On the High Vacuum Body Cavity Drainage System Following Open Heart Surgery (NCT NCT00581399)

Results Overview

The outcome is to measure the amount of postoperative bleeding in cardiac surgery patients from the time the chest is completely closed until the chest tube is pulled out.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

94 participants

Primary outcome timeframe

24-48 hours post surgery

Results posted on

2011-10-31

Participant Flow

Subjects admitted to UCI Medical Center and scheduled for cardiac surgery (Coronary Artery Bypass Graft \[CABG\] with or without Heart valve repair, Heart valve repair alone without CABG) were randomized to one of two study arms: High Vacuum Chest Tubes or Standard of Care Chest Tubes. The enrollment period was from July 2006 through May 2010.

Only subjects that met specific study inclusion/exclusion criteria were enrolled into the study.

Participant milestones

Participant milestones
Measure	No-NumoChest Tubes High Vacuum Chest Tubes 13Fr for Pleural Drainage and 22Fr connected to a Vario High Vacuum Pump (Medela) for Mediastinal Space Drainage.	Standard of Care Chest Tubes Standard of Care 36 Fr Chest Tubes connected to a Pleur-evac Chest Drainage System for Mediastinal Space Drainage.
Overall Study STARTED	46	48
Overall Study COMPLETED	46	48
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Randomized Multicenter Clinical Study On the High Vacuum Body Cavity Drainage System Following Open Heart Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	No-NumoChest Tubes n=46 Participants High Vacuum Chest Tubes 13Fr for Pleural Drainage and 22Fr connected to a Vario High Vacuum Pump (Medela) for Mediastinal Space Drainage.	Standard of Care Chest Tubes n=48 Participants Standard of Care 36 Fr Chest Tubes connected to a Pleur-evac Chest Drainage System for Mediastinal Space Drainage.	Total n=94 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=5 Participants	31 Participants n=7 Participants	62 Participants n=5 Participants
Age, Categorical >=65 years	15 Participants n=5 Participants	17 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	14 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	34 Participants n=7 Participants	70 Participants n=5 Participants
Region of Enrollment United States	46 participants n=5 Participants	48 participants n=7 Participants	94 participants n=5 Participants

PRIMARY outcome

Timeframe: 24-48 hours post surgery

The outcome is to measure the amount of postoperative bleeding in cardiac surgery patients from the time the chest is completely closed until the chest tube is pulled out.

Outcome measures

Outcome measures
Measure	No-NumoChest Tubes n=46 Participants High Vacuum Chest Tubes 13Fr for Pleural Drainage and 22Fr connected to a Vario High Vacuum Pump (Medela) for Mediastinal Space Drainage.	Standard of Care Chest Tubes n=48 Participants Standard of Care 36 Fr Chest Tubes connected to a Pleur-evac Chest Drainage System for Mediastinal Space Drainage.
Amount of Postoperative Bleeding	868.9 mL Standard Deviation 430.17	1467.6 mL Standard Deviation 1224.3

SECONDARY outcome

Timeframe: Immediate postoperative when the chest is completely closed to the time chest tubes are pulled out of the patient

The outcome to measure is the duration of the chest tubes inserted in the patient in hours. The time starts at the time the chest is completely closed and the end time when the chest tubes are pulled out of the patient's chest.

Outcome measures

Outcome measures
Measure	No-NumoChest Tubes n=46 Participants High Vacuum Chest Tubes 13Fr for Pleural Drainage and 22Fr connected to a Vario High Vacuum Pump (Medela) for Mediastinal Space Drainage.	Standard of Care Chest Tubes n=48 Participants Standard of Care 36 Fr Chest Tubes connected to a Pleur-evac Chest Drainage System for Mediastinal Space Drainage.
Duration of Mediastinal Drainage	44.57 Hours Standard Deviation 22.5	54.74 Hours Standard Deviation 32.5

Adverse Events

No-NumoChest Tubes

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care Chest Tubes

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jeffrey C. Milliken

University of California, Irvine Medical Center

Phone: 714-456-3634

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place