Objectives: The effectiveness of treatment with injection of pantoprazole and the oral Rabeprazol in patients with upper gastrointestinal bleeding.
Methods and materials: In this randomized clinical trial, The Patients were excluded from the study if they were pregnant, did not obtain initial haemostasis with endoscopic injection of epinephrine, did not give written informed consent, had bleeding tendency , had uraemia or bleeding gastric cancer. 114 patients were randomly divided into two groups of Pantoprazole 8 mg per hour and edible Rabeprazole 40 mg each 12 hours and the rate of rebleeding, mortality, blood transfusion volume, hospital stay, and need to urgent surgery were compared between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013050713261N1
Registration date:2013-08-03, 1392/05/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-08-03, 1392/05/12
Registrant information
Name
Mohamad amir Sarabi
Name of organization / entity
Shahid sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1823 8605
Email address
masarabi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2011-04-03, 1390/01/14
Expected recruitment end date
2012-11-21, 1391/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of injective pantoprazole and oral Rabeprazol in patients with upper gastrointestinal bleeding
Public title
Gi bleeding treathment
Purpose
Treatment
Inclusion/Exclusion criteria
The patients with upper gastrointestinal bleeding and treated by epinephrine injection who wanted to participate in the study and do not had allergy to the
Inclusion criteria: underwent urgent endoscopy within 24 h after
presentation, had peptic ulcers in the distal oesophagus, stomach or duodenum, had high-risk stigmata including active bleeding , nonbleeding visible vessels , or adherent clots , and successful haemostasis was achieved with endoscopic injection of epinephrine. Written informed consent was obtained before enrolment.
Exclusion criteria:
pregnant; did not obtain initial haemostasis with endoscopic
injection of epinephrine; did not give written
informed consent; had bleeding tendency (platelet count
<50000 , PT > 3 s of normal, CT and BT prolong or were
taking anticoagulants); had uraemia ; bleeding gastric cancer.
Age
From 19 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
114
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
Shahid Sadoughi University of Medical Sciences
Street address
Ebne Sina ave. , , Atlasi sq. , Yazd, Iran
City
Yazd
Postal code
8916886938
Approval date
2013-03-06, 1391/12/16
Ethics committee reference number
17/1/180770/پ
Health conditions studied
1
Description of health condition studied
Upper gibleeding
ICD-10 code
K92.2
ICD-10 code description
Gastrointestinal haemorrhage, unspecified
Primary outcomes
1
Description
No reebleeding
Timepoint
72h
Method of measurement
patient Symptoms and endoscopy in second 24 h
Secondary outcomes
1
Description
Hospital stay and mortality and blood transfusion
Timepoint
72h
Method of measurement
symptoms
Intervention groups
1
Description
Initial treatment included water and electrolyte balancing and injection of Pantoprazole 80 mg and 8 mg per hour and in 24 hours endoscopy was performed on the patients and in patients who had active bleeding or their veins could be seen or had affixed clots based on Rockall, Forrest and Blatch Ford measures epinephrine was injected and if the bleeding was controlled another injection of Pantoprazole was performed in 6 hours and if the clinical signs were stable liquid was started and the patients were randomly (according to random number generator table) divided into two groups a group that continued injection of Pantoprazole 8 mg per hour . Also the drug side effects were determined in the patients.for all patient endoscopy done in 2 th days.
Category
Treatment - Drugs
2
Description
The second group that consumes edible Rabeprazole 40 mg each 12 hours. For all patient endoscopy done in 2 th days.