Protocol summary

Summary
Aim: the efficacy of Helicobacter Pylori eradication in prevention of peptic ulcer recurrence have been verified in different investigations but it's efficacy in preventing of early re bleeding in comparison with PPI infusion has not been elucidated. The aim of this study is comparison of efficacy of these two therapeutic modalities in patients with peptic ulcer bleeding. Method: the bleeding peptic ulcer patients who have stigmata of recent bleeding like active spurting ( Forrest IA), non bleeding visible vessel ( Forrest IIA), oozing or adherent clot with visible vessel ( Forrest IA, IB, IIA) were included in study. Design:after achieving endoscopic homeostasis with epinephrine injection (1:10000) plus APC or bipolar ECT, 2 samples from antrum and 2 from corpus will obtain by forceps biopsy. The samples will check for rapid urease test and all of the positive samples randomly, according to balance block render and with submitting confounding factors like age, sex and endoscopy results divided to 2 groups. Intervention: The group P treat with 80mg IV pantoprazol as bolus and then continuous IV infusion 8mg/h for 48h. The group H have receiv H. pylori eradication regimen including Omeprazole 20mg BID, tetracycline 1000mg BID, metronidazole 500mg BID and bismuth subcytrate 240mg BID for 14 days. Inclusion/exclusion criteria : The bleeding peptic ulcer patients with age ≥ 16 y old who had stigmata of recent bleeding .The exclusion criteria include esophageal varices, liver cirrhosis, malignancy, concomitant morbidity, cardiac pacemaker, NSAID consumption, current therapy with anti coagulant, antibiotic or PPI and multiple ulcers. Outcome:the primary and secondary outcomes define according to rate of re bleeding, need to surgery, number of transfusions and duration of hospitalization in the first week and first month.The patients risk score will determine according to Rockall score and re bleeding define as hematemesis, repeating melena, >2gr/dl decrease in Hb level, pulse rate > 90/min or sudden drop in blood pressure

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201108073836N2
Registration date: 2011-08-23, 1390/06/01
Registration timing: prospective

Last update:
Update count: 0
Registration date
2011-08-23, 1390/06/01
Registrant information
Name
Abdolrahim Masjedi Zadeh
Name of organization / entity
Jundishapour Ahvaz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1337 6922
Email address
rmasjedi@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Jundishapour Ahvaz University of Medical Sciences
Expected recruitment start date
2011-12-14, 1390/09/23
Expected recruitment end date
2012-12-22, 1391/10/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of early Helicobacter Pylori eradication versus continuous pantoprazol infusion in prevention of rebleeding in peptic ulcer patients
Public title
Efficacy of early Helicobacter Pylori eradication versus continuous pantoprazol Infusion in prevention of rebleeding in peptic ulcer patients
Purpose
Prevention
Inclusion/Exclusion criteria
The bleeding peptic ulcer patients with age ≥ 16 y old who have stigmata of recent bleeding like active spurting ( Forrest IA), non bleeding visible vessel ( Forrest IIA), oozing or adherent clot with visible vessel ( Forrest IA, IB, IIA) will be included in study. The exclusion criteria are: esophageal varicose, liver cirrhosis, malignancy, concomitant morbidity, cardiac pacemaker, NSAID consumption, current therapy with anti coagulant, antibiotic or PPI and multiple ulcers.
Age
From 16 years old to 89 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 102
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Jundishapour Ahvaz University of Medical Sciences
Street address
Golestan-University city-Ethnical and research committee of Jundishapour University of Medical Sciences
City
Ahvaz
Postal code
61357-15794
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
u-88016

Health conditions studied

1

Description of health condition studied
Peptic ulcer-GI bleeding
ICD-10 code
k25-k26
ICD-10 code description
Gastric ulcer -Duodenal ulcer -Acute with haemorrhage

Primary outcomes

1

Description
Rebleeding
Timepoint
One week
Method of measurement
Hematemesis, Repeating melena, >2gr/dl Decrease in Hb level, Pulse rate > 90/min or sudden drop in blood pressure

2

Description
Surgery
Timepoint
One Week
Method of measurement
Number

3

Description
Transfustion
Timepoint
One week
Method of measurement
Number

4

Description
Mortality
Timepoint
One week
Method of measurement
Number

5

Description
Duration of admission
Timepoint
One week
Method of measurement
Day

Secondary outcomes

1

Description
Rebleeding
Timepoint
0ne month
Method of measurement
Hematemesis, Repeating melena, >2gr/dl Decrease in Hb level, Pulse rate > 90/min or sudden drop in blood pressure

2

Description
Surgery
Timepoint
One month
Method of measurement
Number

3

Description
Transfustion
Timepoint
One month
Method of measurement
Number

4

Description
Mortality
Timepoint
One month
Method of measurement
Number

5

Description
Duration Admission
Timepoint
One month
Method of measurement
Day

Intervention groups

1

Description
Group H (control group) will be treated by Omeprazole 20mg two times a day(BID), subcytrate bismuth 240mg BID, metronidazole 500mg BID and tetracycline 1000mg BID for 14 days
Category
Treatment - Drugs

2

Description
The group P (case) will receive pantoprazol 80 mg intravenously, stat and then 8mg/h infusion for 72 hours
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hospital
Full name of responsible person
Street address
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Jundishapour Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Feghhi
Street address
Golestan, University city, Vice chancellor for research, Jundishapour University of Medical Sciences
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jundishapour Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Imam Hospital
Full name of responsible person
Abdolrahim Masjedizadeh
Position
Association Professor
Other areas of specialty/work
Street address
Azadgan Street-Imam hospital-Gastroentrology Ward
City
Ahvaz
Postal code
6193673166
Phone
+98 61 1222 2922
Fax
+98 61 1222 5763
Email
rmasjedi@hotmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Imam Hospital
Full name of responsible person
Eskandar Hajiani
Position
Association Professor
Other areas of specialty/work
Street address
Azadgan Street, Imam hospital, Gasterology ward
City
Ahvaz
Postal code
6193673166
Phone
+98 61 1222 2922
Fax
Email
ehajiani@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Imam Hospital
Full name of responsible person
ABDOLRAHIM MASJEDIZADEH
Position
Association Professor
Other areas of specialty/work
Street address
Azadgan street-Imam Hospital-GI Ward
City
Ahvaz
Postal code
6193673166
Phone
+98 61 1222 2922
Fax
+98 61 1222 5762
Email
rmasjedi@hotmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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