Investigation of the effect of Samen-ista emulsion on controlling gastric bleeding through gastric lavage with NG tube in emergency wards
Design
In this study 60 patients with upper gastrointestinal bleeding with normal INR and without platelet disorders who refer to emergency wards will be first hemodynamically investigated and if needed, receive initial resuscitation measures to be stabilized. Then through NG tube, gastric lavage will be done with either normal saline or Samen-ista. Patients are randomly divided to two groups of intervention and control each with 30 people. The grouping is done with Random Block Design.
Settings and conduct
Double blinding is done in a way that only intern and resident of that day in emergency wards of Ghaem Hospitals are aware of which person belongs to which group and the researcher and analyzer are not aware of the grouping.
Participants/Inclusion and exclusion criteria
Patients with upper gastrointestinal bleeding referring to emergency wards of Ghaem Hospital will be included in the study. These patients should not have platelet mal-functioning or Thrombocytopenia or coagulation disorders and should not use Warfarin and Clopidogrel.
Intervention groups
In both groups necessary measures for treating UGIB are taken in emergency wards. But the intervention group, in addition to those measures, will have gastric lavage through NG tube with Samen-ista and then the on-call gastroenterology fellow will be notified to perform endoscopy. During endoscopy, status of bleeding and ulcer will be carefully recorded and the need for endoscopic treatment will be investigated.
Main outcome variables
Increase of speed in stopping bleeding from ulcer in gastric lavage with Samen-ista and reduction of the need for treatment with endoscopy and reduction of hospitalization time and also reduction of bleeding time numbers during hospitalization.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140824018915N5
Registration date:2018-01-15, 1396/10/25
Registration timing:registered_while_recruiting
Last update:2018-01-15, 1396/10/25
Update count:0
Registration date
2018-01-15, 1396/10/25
Registrant information
Name
Mousalreza Hosseini
Name of organization / entity
Mashhad University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 80 1274 2513
Email address
hoseinimr@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-06-21, 1396/03/31
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of Samen-ista emulsion on controlling gastric bleeding through gastric lavage with NG tube in emergency wards.
Public title
Investigation of the effect of Samen-ista emulsion on controlling gastric bleeding through gastric lavage with NG tube.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patients with upper gastrointestinal bleeding who will be admitted in emergency wards of Ghaem Hospital
Exclusion criteria:
Bleeding from esophageal or gastric varices
Bleeding from esophageal or gastric malignancy
Bleeding in a patient with coagulopathy
Hematologic malignancy or renal failure
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Grouping is done with Random Block Design.
Blinding (investigator's opinion)
Double blinded
Blinding description
The intern and resident of the day are only aware of which person belongs to which group and the researcher and analyzer are not aware of the grouping.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9117699199
Approval date
2017-06-21, 1396/03/31
Ethics committee reference number
IR.MUMS.REC.1395.553
Health conditions studied
1
Description of health condition studied
Diseases of esophagus, stomach and duodenum
ICD-10 code
K25.0
ICD-10 code description
Acute gastric ulcer with hemorrhage
Primary outcomes
1
Description
stopping bleeding from ulcer in gastric lavage
Timepoint
During endoscopy
Method of measurement
Through carefully recording bleeding status during endoscopy
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: gastric lavage with Samen-ista emulsion is done through NG tube and then endoscopy is carried out.
Category
Treatment - Drugs
2
Description
Control group: gastric lavage with normal saline is done through NG tube and then endoscopy is carried out.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Dr Mousalreza Hoseini
Street address
Ahmad Abad Ave, Ghaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Email
hoseinimr@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
941742
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mousalreza Hoseini
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Ahmad Abad Ave, Ghaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2742
Email
hoseinimr@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mousalreza Hoseini
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Ahmad Abad Ave, Ghaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2742
Email
hoseinimr@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mousalreza Hoseini
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Ahmad Abad Ave, Ghaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
91766991999
Phone
+98 51 3801 2742
Email
hoseinimr@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
In case organizations ask for the data of participants, the data will become accessible for them.
When the data will become available and for how long
The data can be accessible for specific organization request 6 month after the article is published.
To whom data/document is available
All academic institutes and non-academic industrial institutes which are related to our studies will have access to our data after going through legal procedures.
Under which criteria data/document could be used
In case those people asking for data have the intention of optimizing the study an data and producing more results, access to data is allowed.
From where data/document is obtainable
Through sending an email to the corresponding author, data will be obtainable.
What processes are involved for a request to access data/document
In case someone asks for data, he must first get in contact with the corresponding author for his identity to be fully verified. Then if university allows propagation of data, it will be accessible in 3 months.