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

July 23, 2021 updated by: Hasan Maulahela, MD, Dr Cipto Mangunkusumo General Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
        • Recruiting
        • Dr. Cipto Mangunkusumo General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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: Adrenaline 1 Mg/mL Solution for Injection
injection of adrenaline 1:20.000, followed by thermocoagulation or hemoclip
Drug: Dextrose 40 % in Water
injection of adrenaline 1:20.000, followed by dextrose 40% spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemostatic success
Time Frame: 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.
5 minute

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Re-bleeding
Time Frame: 7 days
Number of participants who experience decrease in hemoglobin >1g/dl or need additional hemostatic endoscopy within one week after intervention
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr Cipto Mangunkusumo General Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2021

Primary Completion (ANTICIPATED)

December 1, 2021

Study Completion (ANTICIPATED)

December 1, 2021

Study Registration Dates

First Submitted

July 2, 2021

First Submitted That Met QC Criteria

July 23, 2021

First Posted (ACTUAL)

July 28, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 28, 2021

Last Update Submitted That Met QC Criteria

July 23, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-02-0130

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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