Role of Doppler Ultrasound in Severe Peptic Ulcer Hemorrhage

Sponsor

Chinese University of Hong Kong (Other)

Overall Status

Terminated

CT.gov ID

NCT00164905

Collaborator

University Hospitals Cleveland Medical Center (Other)

121

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peptic Ulcer Hemorrhage	Device: Doppler ultrasound probe	N/A

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

Study Type:

Interventional

Actual Enrollment :

121 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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

Study Start Date :

Sep 1, 2004

Actual Primary Completion Date :

Aug 1, 2010

Actual Study Completion Date :

Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Doppler ultrasound	Device: Doppler ultrasound probe Applying to ulcer base to assess the blood flow underneath the ulcer Other Names: DOP_US
No Intervention: No Doppler ultrasound

Arm

Intervention/Treatment

Active Comparator: Doppler ultrasound

Device: Doppler ultrasound probe

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

Other Names:

DOP_US

No Intervention: No Doppler ultrasound

Outcome Measures

Primary Outcome Measures

Recurrent bleeding [Within 30 days]

Secondary Outcome Measures

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]
Death [within 56 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.