Back to resultsThe Role of Hypertonic Dextrose Spray as Endoscopic Topical Hemostatic Agent for Acute Non-Variceal Upper GI Bleeding
Primary Purpose
Gastro Intestinal Bleeding
Status
Unknown status
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Dextrose 40 % in Water
Adrenaline 1 Mg/mL Solution for Injection
argon plasma coagulation
Hemoclip
Sponsored by
About this trial
This is an interventional treatment trial for Gastro Intestinal Bleeding
Eligibility Criteria
Inclusion Criteria:
- Patients with acute non-variceal upper gastrointestinal bleeding caused by peptic or duodenal ulcer, polyps, tumors or malignancy
- Patients consented to study participation
Exclusion Criteria:
- Patients with thrombocytopenia (thrombocyte count <100.000 cells/ul) and other forms of coagulopathy
Sites / Locations
- Dr. Cipto Mangunkusumo General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control Group
Dextrose group
Arm Description
Patients within control group will be given adrenaline 1:20.000 injection, followed by thermocoagulation or hemoclip
Patients within this group will be given adrenaline 1:20.000 injection, followed by dextrose 40% spray
Outcomes
Primary Outcome Measures
Hemostatic success
Number of participants whose bleeding stops within five minutes after intervention is given. Outcome is assessed by independent assessor (not the endoscopy operator), who also attend the endoscopy session and could observe whether the bleeding stops.
Secondary Outcome Measures
Re-bleeding
Number of participants who experience decrease in hemoglobin >1g/dl or need additional hemostatic endoscopy within one week after intervention
Full Information
NCT ID
NCT04979273
First Posted
July 2, 2021
Last Updated
July 23, 2021
Sponsor
Dr Cipto Mangunkusumo General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04979273
Brief Title
The Role of Hypertonic Dextrose Spray as Endoscopic Topical Hemostatic Agent for Acute Non-Variceal Upper GI Bleeding
Official Title
The Role of Hypertonic Dextrose Spray as Endoscopic Topical Hemostatic Agent for Acute Non-Variceal Upper Gastrointestinal Bleeding: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr Cipto Mangunkusumo General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study is conducted to evaluate the effectivity of hypertonic dextrose spray as an endoscopic topical hemostatic agent, compared to conventional agent (adrenaline injection, followed by hemoclip or thermocoagulation), in patients with acute non-variceal upper GI bleeding.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastro Intestinal Bleeding
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Patients within control group will be given adrenaline 1:20.000 injection, followed by thermocoagulation or hemoclip
Arm Title
Dextrose group
Arm Type
Experimental
Arm Description
Patients within this group will be given adrenaline 1:20.000 injection, followed by dextrose 40% spray
Intervention Type
Drug
Intervention Name(s)
Dextrose 40 % in Water
Intervention Description
injection of adrenaline 1:20.000, followed by dextrose 40% spray
Intervention Type
Drug
Intervention Name(s)
Adrenaline 1 Mg/mL Solution for Injection
Intervention Description
injection of adrenaline 1:20.000, followed by thermocoagulation or hemoclip
Intervention Type
Procedure
Intervention Name(s)
argon plasma coagulation
Intervention Description
Thermocoagulation
Intervention Type
Procedure
Intervention Name(s)
Hemoclip
Intervention Description
Hemoclip
Primary Outcome Measure Information:
Title
Hemostatic success
Description
Number of participants whose bleeding stops within five minutes after intervention is given. Outcome is assessed by independent assessor (not the endoscopy operator), who also attend the endoscopy session and could observe whether the bleeding stops.
Time Frame
5 minute
Secondary Outcome Measure Information:
Title
Re-bleeding
Description
Number of participants who experience decrease in hemoglobin >1g/dl or need additional hemostatic endoscopy within one week after intervention
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with acute non-variceal upper gastrointestinal bleeding caused by peptic or duodenal ulcer, polyps, tumors or malignancy
Patients consented to study participation
Exclusion Criteria:
Patients with thrombocytopenia (thrombocyte count <100.000 cells/ul) and other forms of coagulopathy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hasan Maulahela, MD
Phone
+6281283602549
Email
hasanmaulahela@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hasan Maulahela, MD
Organizational Affiliation
Dr Cipto Mangunkusumo General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Cipto Mangunkusumo General Hospital
City
Jakarta Pusat
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hasan Maulahela, MD
Phone
+6281283602549
Email
hasanmaulahela@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Role of Hypertonic Dextrose Spray as Endoscopic Topical Hemostatic Agent for Acute Non-Variceal Upper GI Bleeding
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