Trial Outcomes & Findings for A2ALL-Patients Safety System Improvements in Living Donor Liver Transplantation (NCT NCT02073435)
NCT ID: NCT02073435
Last Updated: 2018-12-05
Results Overview
Comparison of Average Pain Scores on Visual Analogue Pain Scale (0-10) measured before and after implementation of evidence-based donor pain management solution. 0 representing "No Pain", up through 10 representing "Worst possible, unbearable, excruciating pain".
Recruitment status
COMPLETED
Target enrollment
177 participants
Primary outcome timeframe
Daily Visual Analogue Pain Scores (0-10) At transplant (post-operative day 0) and throughout hospitalization (post-operative days 1-8)
Results posted on
2018-12-05
Participant Flow
Participant milestones
| Measure |
Post-Implementation Group
Living Donor Liver Transplant patients with evidence based donor pain management solution.
|
Pre-Implementation Group
Living Donor Liver Transplant patients prior to the implementation of the evidence based donor pain management solution.
|
|---|---|---|
|
Overall Study
STARTED
|
81
|
96
|
|
Overall Study
COMPLETED
|
81
|
96
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A2ALL-Patients Safety System Improvements in Living Donor Liver Transplantation
Baseline characteristics by cohort
| Measure |
Post-Implementation Group
n=81 Participants
Living Donor Liver Transplant patients with evidence based donor pain management solution.
|
Pre-Implementation Group
n=96 Participants
Living Donor Liver Transplant patients prior to the implementation of the evidence based donor pain management solution.
|
Total
n=177 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.96 Years
STANDARD_DEVIATION 10.82 • n=5 Participants
|
38.81 Years
STANDARD_DEVIATION 11.04 • n=7 Participants
|
38.88 Years
STANDARD_DEVIATION 10.99 • n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
67 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
153 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
60 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Daily Visual Analogue Pain Scores (0-10) At transplant (post-operative day 0) and throughout hospitalization (post-operative days 1-8)Comparison of Average Pain Scores on Visual Analogue Pain Scale (0-10) measured before and after implementation of evidence-based donor pain management solution. 0 representing "No Pain", up through 10 representing "Worst possible, unbearable, excruciating pain".
Outcome measures
| Measure |
Post-Implementation Group
n=81 Participants
Living Donor Liver Transplant patients with evidence based donor pain management solution.
|
Pre-Implementation Group
n=96 Participants
Living Donor Liver Transplant patients prior to the implementation of the evidence based donor pain management solution.
|
|---|---|---|
|
Living Donor Pain Management
Post-Operative Day 0 (Surgery Day)
|
2.62 Scores on Visual Analogue Pain Scale
Standard Deviation 1.85
|
2.56 Scores on Visual Analogue Pain Scale
Standard Deviation 2.17
|
|
Living Donor Pain Management
Post-Operative Day 1
|
2.87 Scores on Visual Analogue Pain Scale
Standard Deviation 1.76
|
2.67 Scores on Visual Analogue Pain Scale
Standard Deviation 1.42
|
|
Living Donor Pain Management
Post-Operative Day 2
|
3.25 Scores on Visual Analogue Pain Scale
Standard Deviation 1.89
|
2.79 Scores on Visual Analogue Pain Scale
Standard Deviation 1.65
|
|
Living Donor Pain Management
Post-Operative Day 3
|
3.56 Scores on Visual Analogue Pain Scale
Standard Deviation 1.94
|
2.84 Scores on Visual Analogue Pain Scale
Standard Deviation 1.93
|
|
Living Donor Pain Management
Post-Operative Day 4
|
3.56 Scores on Visual Analogue Pain Scale
Standard Deviation 1.90
|
3.14 Scores on Visual Analogue Pain Scale
Standard Deviation 2.00
|
|
Living Donor Pain Management
Post-Operative Day 5
|
3.11 Scores on Visual Analogue Pain Scale
Standard Deviation 2.20
|
3.36 Scores on Visual Analogue Pain Scale
Standard Deviation 2.14
|
|
Living Donor Pain Management
Post-Operative Day 6
|
3.39 Scores on Visual Analogue Pain Scale
Standard Deviation 2.04
|
4.10 Scores on Visual Analogue Pain Scale
Standard Deviation 2.39
|
|
Living Donor Pain Management
Post-Operative Day 7
|
3.47 Scores on Visual Analogue Pain Scale
Standard Deviation 2.18
|
2.69 Scores on Visual Analogue Pain Scale
Standard Deviation 2.18
|
|
Living Donor Pain Management
Post-Operative Day 8
|
4.06 Scores on Visual Analogue Pain Scale
Standard Deviation 2.92
|
2.81 Scores on Visual Analogue Pain Scale
Standard Deviation 2.00
|
PRIMARY outcome
Timeframe: PerioperativelyCardiopulmonary complications
Outcome measures
| Measure |
Post-Implementation Group
n=81 Participants
Living Donor Liver Transplant patients with evidence based donor pain management solution.
|
Pre-Implementation Group
n=96 Participants
Living Donor Liver Transplant patients prior to the implementation of the evidence based donor pain management solution.
|
|---|---|---|
|
Complications
|
0 Cardiopulmonary complications
|
12 Cardiopulmonary complications
|
Adverse Events
Post-Implementation Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pre-Implementation Group
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place