Bleeding Clinical Trial
Official title:
Early Selective Angiographic Embolization to Severely Bleeding Peptic Ulcers After Their Initial Endoscopic Hemostasis - a Randomized Controlled Trial
NCT number | NCT01142180 |
Other study ID # | TAE2 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2010 |
Est. completion date | July 2014 |
Verified date | July 2018 |
Source | Chinese University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to determine if early angiographic embolization can forestall recurrent bleeding in selected high risk ulcers after their initial endoscopic control; to validate prospectively the investigators proposed in selecting high risk ulcers for recurrent bleeding in spite of maximal endoscopic control and profound acid suppression using high dose intravenous infusion of proton pump inhibitor; to characterize the nature of bleeding arteries in severely bleeding peptic ulcers and determine the efficacy of angiographic embolization in the prevention of recurrent bleeding and to establish safety profile of angiographic embolization as an early elective treatment to bleeding peptic ulcers.
Status | Completed |
Enrollment | 258 |
Est. completion date | July 2014 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Actively bleeding peptic ulcers (Forrest I), NBVV or Forrest IIa ulcer, - Successful endoscopic hemostasis by combination treatment of injected epinephrine followed by either 3.2mm heat probe 30J (4 continuous pulses) or hemo-clipping (at least 2 clips) And one of the followings - Spurting hemorrhage during endoscopy; - Ulcer >= 2 cm is determined by an opened biopsy forceps; - Hb on admission of < 9 g/dl; or - Hypotension prior to endoscopy defined by SBP of <90 mmHg AND HR of >110 bmp Exclusion Criteria: |
Country | Name | City | State |
---|---|---|---|
China | Endoscopy Centre, Prince of Wales Hospital | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong | King Chulalongkorn Memorial Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | clinical re-bleeding | Clinical rebleeding is defined by fresh hematemesis, fresh melena or hematochezia and signs of hypovolemic shock (systolic blood pressure of <90mmHg and pulse rate >110 per minute) and a drop in hemoglobin of > 2 g/dl per 24 hours despite adequate transfusion. Rebleeding will be confirmed by an immediate endoscopy showing fresh blood in stomach or active bleeding from a previously seen ulcer. A clinical rebleeding will be independently reviewed by an adjudication panel. |
within 30 days of therapy | |
Secondary | death from all causes | death from all causes | within 30 days of therapy | |
Secondary | transfusion requirement | transfusion requirement | within 30 days of therapy | |
Secondary | hospital stay including Intensive Care Unit stay | hospital stay including Intensive Care Unit stay | within 30 days of therapy | |
Secondary | further interventions either further TAE or surgery | further interventions either further TAE or surgery | within 30 days of therapy | |
Secondary | hospital costs | hospital costs | within 30 days of therapy |
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