Role of Doppler Ultrasound in Severe Peptic Ulcer Hemorrhage

NCT00164905 | Terminated

• 1 other identifier: DOP-US study
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peptic Ulcer Hemorrhage

Keywords

Peptic ulcer hemorrhage; Doppler ultrasound

Outcome Measures

Primary Outcomes (1)

• Recurrent bleeding

  Within 30 days

Secondary Outcomes (6)

• Length of stay

  Within 56 days

• ICU utilization

  Within 56 days

• Blood Transfusion during hospital

  Within 56 days

• Need for urgent/emergent ulcer surgery for bleeding

  Within 56 days

• Need for angiographic treatment of bleeding

  Within 56 days

Study Arms (2)

Doppler ultrasound

ACTIVE COMPARATOR

Device: Doppler ultrasound probe

No Doppler ultrasound

NO INTERVENTION

Interventions

Doppler ultrasound probe DEVICE

Applying to ulcer base to assess the blood flow underneath the ulcer

Also known as: DOP_US

Doppler ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• University Hospitals Cleveland Medical Center: collaborator

Study Sites (1)

Endoscopy Center, Prince of Wales Hospital

Hong Kong SAR, China

Location

MeSH Terms

Conditions

Peptic Ulcer Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal Hemorrhage; Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• James Y Lau, MD

  Prince of Wales Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 14, 2005
• Study Start: September 1, 2004
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: August 28, 2012

Record last verified: 2012-08

Locations

CN (1)