Trial Outcomes & Findings for Doppler Ultrasound Probe for Blood Flow Detection in Severe Upper Gastrointestinal Hemorrhage (NCT NCT00732212)
NCT ID: NCT00732212
Last Updated: 2023-12-04
Results Overview
The primary outcome is index lesion rebleeding rate up to 30 days in 2 subgroups- non-variceal or variceal-portal hypertension lesions according to standard visually guided hemostasis vs. Doppler assisted.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
235 participants
Primary outcome timeframe
30 days
Results posted on
2023-12-04
Participant Flow
Participant milestones
| Measure |
Doppler Endoscopic Probe Assisted Hemostasis
In addition to stigmata of hemorrhage and visual cues, Doppler endoscopic probe will be used for detection of blood flow before and after standard endoscopic hemostasis. If residual blood flow in the lesion is found after standard treatment, further endoscopic treatment will be applied as deemed safe by the investigator-endoscopist.
Doppler endoscopic ultrasound probe is used for blood flow detection
|
Standard Endoscopic Hemostasis
Standard, visually guided endoscopic hemostasis based on visual cues of stigmata of hemorrhage and endoscopic control of bleeding or treatment of the stigmata according to current guidelines
Standard endoscopic hemostasis: Per current treatment guidelines for non-variceal UGI lesions - based upon stigmata of hemorrhage \& visual cues for risk stratification and completion of endoscopic treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
112
|
123
|
|
Overall Study
Temporarily Suspended
|
50
|
50
|
|
Overall Study
COMPLETED
|
112
|
123
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Doppler Ultrasound Probe for Blood Flow Detection in Severe Upper Gastrointestinal Hemorrhage
Baseline characteristics by cohort
| Measure |
Standard Non-variceal Group
n=76 Participants
Standard non-variceal treatment patient characteristics, risk factors and the primary outcome (rebleed with 30 days) were analyzed. Each specified variable and 30 day lesion rebleeding were compared between the two treatment groups separately by time period using the Chi-Square or Fisher exact tests (for categorical variables) or the Wilcoxon rank sum test (for continuous variables).
|
Doppler Non-variceal Group
n=72 Participants
Doppler non-variceal treatment patient characteristics, risk factors and the primary outcome (rebleed with 30 days) were analyzed. Each specified variable and 30 day lesion rebleeding were compared between the two treatment groups separately by time period using the Chi-Square or Fisher exact tests (for categorical variables) or the Wilcoxon rank sum test (for continuous variables).
|
Standard Variceal Group
n=47 Participants
Standard variceal treatment patient characteristics, risk factors and the primary outcome (rebleed with 30 days) were analyzed. Each specified variable and 30 day lesion rebleeding were compared between the two treatment groups separately by time period using the Chi-Square or Fisher exact tests (for categorical variables) or the Wilcoxon rank sum test (for continuous variables).
|
Doppler Variceal Group
n=40 Participants
Doppler variceal treatment patient characteristics, risk factors and the primary outcome (rebleed with 30 days) were analyzed. Each specified variable and 30 day lesion rebleeding were compared between the two treatment groups separately by time period using the Chi-Square or Fisher exact tests (for categorical variables) or the Wilcoxon rank sum test (for continuous variables).
|
Total
n=235 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
66 Years
STANDARD_DEVIATION 16.1 • n=5 Participants
|
65 Years
STANDARD_DEVIATION 15.6 • n=7 Participants
|
57.1 Years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
54.7 Years
STANDARD_DEVIATION 11.7 • n=4 Participants
|
60.7 Years
STANDARD_DEVIATION 5.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
194 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
66 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
194 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
21 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
175 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
76 participants
n=5 Participants
|
72 participants
n=7 Participants
|
47 participants
n=5 Participants
|
40 participants
n=4 Participants
|
235 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 30 daysThe primary outcome is index lesion rebleeding rate up to 30 days in 2 subgroups- non-variceal or variceal-portal hypertension lesions according to standard visually guided hemostasis vs. Doppler assisted.
Outcome measures
| Measure |
Standard Non-variceal Group
n=76 Participants
30 day rebleeding rate in standard non-variceal visually guided hemostasis patients.
|
Doppler Non-variceal Group
n=72 Participants
30 day rebleeding rate in Doppler assisted non-variceal patients.
|
Standard Variceal Group
n=47 Participants
30 day rebleeding rate in standard variceal visually guided hemostasis patients.
|
Doppler Variceal Group
n=40 Participants
30 day rebleeding rate in Doppler assisted variceal patients.
|
|---|---|---|---|---|
|
30 Day Rebleeding Rate
|
20 Participants
|
8 Participants
|
17 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 30 daysGI surgery rate for control of active bleeding or rebleeding - up to 30 days after randomization in 2 subgroups- non-variceal or variceal-portal hypertension lesions according to standard visually guided hemostasis vs. Doppler assisted.
Outcome measures
| Measure |
Standard Non-variceal Group
n=76 Participants
30 day rebleeding rate in standard non-variceal visually guided hemostasis patients.
|
Doppler Non-variceal Group
n=72 Participants
30 day rebleeding rate in Doppler assisted non-variceal patients.
|
Standard Variceal Group
n=47 Participants
30 day rebleeding rate in standard variceal visually guided hemostasis patients.
|
Doppler Variceal Group
n=40 Participants
30 day rebleeding rate in Doppler assisted variceal patients.
|
|---|---|---|---|---|
|
Rates of Surgery up to 30 Days After Randomization
|
4 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 daysRates for each treatment group will be determined and compared for General medical complications (pneumonia, infection, myocardial infarction, stroke) \& GI procedure related (perforation, aspiration) up to 30 days in 2 subgroups- non-variceal or variceal-portal hypertension lesions according to standard visually guided hemostasis vs. Doppler assisted.
Outcome measures
| Measure |
Standard Non-variceal Group
n=76 Participants
30 day rebleeding rate in standard non-variceal visually guided hemostasis patients.
|
Doppler Non-variceal Group
n=72 Participants
30 day rebleeding rate in Doppler assisted non-variceal patients.
|
Standard Variceal Group
n=47 Participants
30 day rebleeding rate in standard variceal visually guided hemostasis patients.
|
Doppler Variceal Group
n=40 Participants
30 day rebleeding rate in Doppler assisted variceal patients.
|
|---|---|---|---|---|
|
Rate of Complications
|
4 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 30 daysDeath up to 30 days from a co-morbid condition, bleeding, or another cause in 2 subgroups- non-variceal or variceal-portal hypertension lesions according to standard visually guided hemostasis vs. Doppler assisted.
Outcome measures
| Measure |
Standard Non-variceal Group
n=76 Participants
30 day rebleeding rate in standard non-variceal visually guided hemostasis patients.
|
Doppler Non-variceal Group
n=72 Participants
30 day rebleeding rate in Doppler assisted non-variceal patients.
|
Standard Variceal Group
n=47 Participants
30 day rebleeding rate in standard variceal visually guided hemostasis patients.
|
Doppler Variceal Group
n=40 Participants
30 day rebleeding rate in Doppler assisted variceal patients.
|
|---|---|---|---|---|
|
Death
|
3 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 daysRBC units of transfusion post-randomization will be quantitated \& compared in 2 subgroups- non-variceal or variceal-portal hypertension lesions according to standard visually guided hemostasis vs. Doppler assisted.
Outcome measures
| Measure |
Standard Non-variceal Group
n=76 Participants
30 day rebleeding rate in standard non-variceal visually guided hemostasis patients.
|
Doppler Non-variceal Group
n=72 Participants
30 day rebleeding rate in Doppler assisted non-variceal patients.
|
Standard Variceal Group
n=47 Participants
30 day rebleeding rate in standard variceal visually guided hemostasis patients.
|
Doppler Variceal Group
n=40 Participants
30 day rebleeding rate in Doppler assisted variceal patients.
|
|---|---|---|---|---|
|
Units of Red Blood Cells (RBC) Transfused for Rebleeding After Randomization
|
1.09 Units of RBC
Standard Deviation 2.94
|
0.56 Units of RBC
Standard Deviation 2.41
|
2.00 Units of RBC
Standard Deviation 5.48
|
1.33 Units of RBC
Standard Deviation 6.36
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 daysComparisons of days spent in the ICU and hospital will be quantitated \& compared in 2 subgroups- non-variceal or variceal-portal hypertension lesions according to standard visually guided hemostasis vs. Doppler assisted.
Outcome measures
| Measure |
Standard Non-variceal Group
n=76 Participants
30 day rebleeding rate in standard non-variceal visually guided hemostasis patients.
|
Doppler Non-variceal Group
n=72 Participants
30 day rebleeding rate in Doppler assisted non-variceal patients.
|
Standard Variceal Group
n=47 Participants
30 day rebleeding rate in standard variceal visually guided hemostasis patients.
|
Doppler Variceal Group
n=40 Participants
30 day rebleeding rate in Doppler assisted variceal patients.
|
|---|---|---|---|---|
|
Hospital Days After Randomization
|
7 Days
Standard Deviation 8.79
|
6.65 Days
Standard Deviation 8.48
|
11.32 Days
Standard Deviation 10.55
|
7.18 Days
Standard Deviation 8.83
|
Adverse Events
Standard Non-variceal Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Doppler Non-variceal Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Standard Variceal Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Doppler Variceal Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dennis M. Jensen, M.D.
CURE Digestive Diseases Research Center
Phone: 310-268-3569
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place