The Role of Hypertonic Dextrose Spray as Endoscopic Topical Hemostatic Agent for Acute Non-Variceal Upper GI Bleeding

Sponsor

Dr Cipto Mangunkusumo General Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04979273

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

7.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gastro Intestinal Bleeding	Drug: Dextrose 40 % in Water Drug: Adrenaline 1 Mg/mL Solution for Injection Procedure: argon plasma coagulation Procedure: Hemoclip	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Role of Hypertonic Dextrose Spray as Endoscopic Topical Hemostatic Agent for Acute Non-Variceal Upper Gastrointestinal Bleeding: A Randomized Controlled Trial

Actual Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control Group Patients within control group will be given adrenaline 1:20.000 injection, followed by thermocoagulation or hemoclip	Drug: Adrenaline 1 Mg/mL Solution for Injection injection of adrenaline 1:20.000, followed by thermocoagulation or hemoclip Procedure: argon plasma coagulation Thermocoagulation Procedure: Hemoclip Hemoclip
Experimental: Dextrose group Patients within this group will be given adrenaline 1:20.000 injection, followed by dextrose 40% spray	Drug: Dextrose 40 % in Water injection of adrenaline 1:20.000, followed by dextrose 40% spray Drug: Adrenaline 1 Mg/mL Solution for Injection injection of adrenaline 1:20.000, followed by thermocoagulation or hemoclip

Arm

Intervention/Treatment

Active Comparator: Control Group

Patients within control group will be given adrenaline 1:20.000 injection, followed by thermocoagulation or hemoclip

Drug: Adrenaline 1 Mg/mL Solution for Injection

injection of adrenaline 1:20.000, followed by thermocoagulation or hemoclip

Procedure: argon plasma coagulation

Thermocoagulation

Procedure: Hemoclip

Hemoclip

Experimental: Dextrose group

Patients within this group will be given adrenaline 1:20.000 injection, followed by dextrose 40% spray

Drug: Dextrose 40 % in Water

injection of adrenaline 1:20.000, followed by dextrose 40% spray

Drug: Adrenaline 1 Mg/mL Solution for Injection

injection of adrenaline 1:20.000, followed by thermocoagulation or hemoclip

Outcome Measures

Primary Outcome Measures

Hemostatic success [5 minute]
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 [7 days]
Number of participants who experience decrease in hemoglobin >1g/dl or need additional hemostatic endoscopy within one week after intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dr. Cipto Mangunkusumo General Hospital	Jakarta Pusat	DKI Jakarta	Indonesia	10430

Sponsors and Collaborators

Dr Cipto Mangunkusumo General Hospital

Investigators

Principal Investigator: Hasan Maulahela, MD, Dr Cipto Mangunkusumo General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hasan Maulahela, MD, Head of Gastrointestinal Endoscopy Center FKUI-RSCM, Dr Cipto Mangunkusumo General Hospital

ClinicalTrials.gov Identifier:

NCT04979273

Other Study ID Numbers:

20-02-0130

First Posted:

Jul 28, 2021

Last Update Posted:

Jul 28, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Gastrointestinal Hemorrhage

Study Results

No Results Posted as of Jul 28, 2021