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

Gastro Intestinal Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04979273
• Other study ID #: 20-02-0130
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: December 2021

Study information

• Verified date: July 2021
• Source: Dr Cipto Mangunkusumo General Hospital
• Contact: Hasan Maulahela, MD
• Phone: +6281283602549
• Email: hasanmaulahela[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastro Intestinal Bleeding
• Gastrointestinal Hemorrhage
• Hemorrhage

Intervention

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

Procedure:
• argon plasma coagulation
Thermocoagulation
• Hemoclip
Hemoclip

Locations

Country	Name	City	State
Indonesia	Dr. Cipto Mangunkusumo General Hospital	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Dr Cipto Mangunkusumo General Hospital

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 minute
Secondary	Re-bleeding	Number of participants who experience decrease in hemoglobin >1g/dl or need additional hemostatic endoscopy within one week after intervention	7 days