Peptic Ulcer HemorrhageNCT00164905
Role of Doppler Ultrasound in Severe Peptic Ulcer Hemorrhage
A study testing Doppler ultrasound probe in people with Peptic Ulcer Hemorrhage, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
The aim of study is to evaluate whether Doppler ultrasound can accurately identify patients who are at risk of recurrent bleeding, who will require endoscopic therapy, and who will fail endoscopic therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peptic Ulcer Hemorrhage
- What is being tested?
- Doppler ultrasound probe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteChina
- Study dates
- Sep 2004to Aug 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clean base ulcer with severe upper GIB (defined as melaena, hematochezia, hematemesis, and/or gross blood in NG lavage), and any one of the following:
- SBP ≤ 90mmHg; P of ≥110 bpm; or orthostatic changes with SBP drops 20mmHg or P increases 20 bpm; or,
- Transfusion of 2 or more units of packed red blood cells within 12 hrs of admission; or,
- A documented HCT drop of at lest 6% from baseline.
- Endoscopically confirmed bleeding from GU, DU, pyloric ulcer, or anastomotic ulcer
- Pt can either have primary or secondary acute UGI haemorrhage
Who cannot join
- Bleeding site from lesion other than GU, DU, pyloric or anastomotic ulcer
- there is more than one type of significant bleeding lesion
- Documented hx of cirrhosis / portal HT
- ESRF requiring any form of dialysis
- Expected or persistent (>24hrs) coagulopathy with INR> 1.5
- Platelet count is under 50000/mm3
Show all 11Show fewer
- Aspirin User / Plavix [Clopidogrel] User
- If the ulcer is neoplastic
- Cannot obtained consent
- Age < 18 or is pregnant
- Severe comorbid of which life expectancy <30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Doppler Ultrasound in Severe Peptic Ulcer Hemorrhage: Can it Guide the Use of and Predict Failure of Endoscopic Treatment? A Prospective, Multicenter, Randomized, Controlled Study
The aim of study is to evaluate whether Doppler ultrasound can accurately identify patients who are at risk of recurrent bleeding, who will require endoscopic therapy, and who will fail endoscopic therapy.
Read the detailed description
Bleeding peptic ulcer is a life-threatening emergency. Endoscopic therapy is a proven technique in the acute hemostasis of bleeding ulcers. Currently there is no objective assessment of adequacy of endoscopic therapy. Endoscopic Doppler ultrasound enables endoscopists in detecting blood flow in a vessel beneath an ulcer. A persistent signal after endoscopic therapy predicts recurrent bleeding. The current study proposes to compare assessment of ulcer base using either Doppler ultrasound or endoscopists' interpretation of ulcer floors. The trial design is one of a prospective randomized controlled cross-over study in which patients with severe upper gastrointestinal bleeding and documented peptic ulcers at endoscopy are enrolled.
- Conditions
- Peptic Ulcer Hemorrhage
- Being tested
- Doppler ultrasound probe
- Keywords
- Peptic ulcer hemorrhage, Doppler ultrasound
- Medical subject headings
- Peptic Ulcer Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doppler ultrasound probeDevice
Also called DOP_US
Applying to ulcer base to assess the blood flow underneath the ulcer
| Study group | Role | What they receive |
|---|---|---|
| Doppler ultrasound | Active comparator | Not described Receives: Device: Doppler ultrasound probe |
| No Doppler ultrasound | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent bleeding
Measured: Within 30 days
Secondary outcomes (6)
Length of stay
Measured: Within 56 days
ICU utilization
Measured: Within 56 days
Blood Transfusion during hospital
Measured: Within 56 days
Need for urgent/emergent ulcer surgery for bleeding
Measured: Within 56 days
Need for angiographic treatment of bleeding
Measured: Within 56 days
Death
Measured: within 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startSep 2004
- Primary completionAug 2010
- Study completionAug 2010
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peptic Ulcer HemorrhageStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals Cleveland Medical Center
- Responsible party
- Principal investigator, James Yun-wong Lau, Chinese University of Hong Kong
- Investigators
- James Y Lau, MD, Principal investigator, Prince of Wales Hospital, Shatin, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00164905
- Sponsor's protocol ID
- DOP-US study
- Status last verified
- Aug 2012
- First submitted
- 12 Sep 2005
- Last updated
- 28 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Doppler Ultrasound in Severe Peptic Ulcer Hemorrhage: Can it Guide the Use of and Predict Failure of Endoscopic Treatment? A Prospective, Multicenter, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT00164905
- Acronym / sponsor ID
- DOP-US study
- Conditions
- Peptic Ulcer Hemorrhage
- Keywords
- Peptic ulcer hemorrhage, Doppler ultrasound
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- University Hospitals Cleveland Medical Center
- Study start
- Sep 2004
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of study is to evaluate whether Doppler ultrasound can accurately identify patients who are at risk of recurrent bleeding, who will require endoscopic therapy, and who will fail endoscopic therapy.
Detailed description
Bleeding peptic ulcer is a life-threatening emergency. Endoscopic therapy is a proven technique in the acute hemostasis of bleeding ulcers. Currently there is no objective assessment of adequacy of endoscopic therapy. Endoscopic Doppler ultrasound enables endoscopists in detecting blood flow in a vessel beneath an ulcer. A persistent signal after endoscopic therapy predicts recurrent bleeding. The current study proposes to compare assessment of ulcer base using either Doppler ultrasound or endoscopists' interpretation of ulcer floors. The trial design is one of a prospective randomized controlled cross-over study in which patients with severe upper gastrointestinal bleeding and documented peptic ulcers at endoscopy are enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doppler ultrasound | Active comparator | Device: Doppler ultrasound probe |
| No Doppler ultrasound | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clean base ulcer with severe upper GIB (defined as melaena, hematochezia, hematemesis, and/or gross blood in NG lavage), and any one of the following:
- Endoscopically confirmed bleeding from GU, DU, pyloric ulcer, or anastomotic ulcer
- Pt can either have primary or secondary acute UGI haemorrhage
Key exclusion criteria (11 listed)
- Bleeding site from lesion other than GU, DU, pyloric or anastomotic ulcer
- there is more than one type of significant bleeding lesion
- Documented hx of cirrhosis / portal HT
- ESRF requiring any form of dialysis
- Expected or persistent (>24hrs) coagulopathy with INR> 1.5
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doppler ultrasound probeAlso: DOP_USApplying to ulcer base to assess the blood flow underneath the ulcer | Device | Doppler ultrasound |
Primary outcome
Recurrent bleeding
Time frame: Within 30 days
6 secondary outcomes
Length of stay
Time frame: Within 56 days
ICU utilization
Time frame: Within 56 days
Blood Transfusion during hospital
Time frame: Within 56 days
Need for urgent/emergent ulcer surgery for bleeding
Time frame: Within 56 days
Need for angiographic treatment of bleeding
Time frame: Within 56 days
Death
Time frame: within 56 days
Results and safety
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Y Lau, MD principal investigator
Prince of Wales Hospital, Shatin, Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doppler ultrasound probe in people with Peptic Ulcer Hemorrhage, run by Chinese University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent bleeding (time frame: Within 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2012.