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

NCT ID: NCT04979273

Last Updated: 2021-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastro Intestinal Bleeding

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control Group

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

Group Type ACTIVE_COMPARATOR

Adrenaline 1 Mg/mL Solution for Injection

Intervention Type DRUG

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

argon plasma coagulation

Intervention Type PROCEDURE

Thermocoagulation

Hemoclip

Intervention Type PROCEDURE

Hemoclip

Dextrose group

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

Group Type EXPERIMENTAL

Dextrose 40 % in Water

Intervention Type DRUG

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

Adrenaline 1 Mg/mL Solution for Injection

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dextrose 40 % in Water

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

Intervention Type DRUG

Adrenaline 1 Mg/mL Solution for Injection

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

Intervention Type DRUG

argon plasma coagulation

Thermocoagulation

Intervention Type PROCEDURE

Hemoclip

Hemoclip

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dr Cipto Mangunkusumo General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hasan Maulahela, MD

Head of Gastrointestinal Endoscopy Center FKUI-RSCM

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hasan Maulahela, MD

Role: PRINCIPAL_INVESTIGATOR

Dr Cipto Mangunkusumo General Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dr. Cipto Mangunkusumo General Hospital

Jakarta Pusat, DKI Jakarta, Indonesia

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Indonesia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Hasan Maulahela, MD

Role: CONTACT

+6281283602549

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Hasan Maulahela, MD

Role: primary

+6281283602549

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20-02-0130

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.