Gastro Intestinal BleedingNCT04979273
The Role of Hypertonic Dextrose Spray as Endoscopic Topical Hemostatic Agent for Acute Non-Variceal Upper GI Bleeding
A study testing Dextrose 40 % in Water, Adrenaline 1 Mg/mL Solution for Injection and argon plasma coagulation in people with Gastro Intestinal Bleeding, run by Dr Cipto Mangunkusumo General Hospital at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastro Intestinal Bleeding
- What is being tested?
- Dextrose 40 % in Water, Adrenaline 1 Mg/mL Solution for Injection and argon plasma coagulation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Mar 2021to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with acute non-variceal upper gastrointestinal bleeding caused by peptic or duodenal ulcer, polyps, tumors or malignancy
- Patients consented to study participation
Who cannot join
- Patients with thrombocytopenia (thrombocyte count <100.000 cells/ul) and other forms of coagulopathy
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Dr. Cipto Mangunkusumo General Hospital
Jakarta Pusat, DKI Jakarta, 10430
Hasan Maulahela, MD, +6281283602549, hasanmaulahela@yahoo.com
About this study
Official title: 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.
- Conditions
- Gastro Intestinal Bleeding
- Being tested
- Dextrose 40 % in Water, Adrenaline 1 Mg/mL Solution for Injection, argon plasma coagulation, Hemoclip
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dextrose 40 % in WaterDrug
injection of adrenaline 1:20.000, followed by dextrose 40% spray
Adrenaline 1 Mg/mL Solution for InjectionDrug
injection of adrenaline 1:20.000, followed by thermocoagulation or hemoclip
argon plasma coagulationProcedure or surgery
Thermocoagulation
HemoclipProcedure or surgery
Hemoclip
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Patients within control group will be given adrenaline 1:20.000 injection, followed by thermocoagulation or hemoclip Receives: Drug: Adrenaline 1 Mg/mL Solution for Injection; Procedure: argon plasma coagulation; Procedure: Hemoclip |
| Dextrose group | Experimental | Patients within this group will be given adrenaline 1:20.000 injection, followed by dextrose 40% spray Receives: Drug: Dextrose 40 % in Water; Drug: Adrenaline 1 Mg/mL Solution for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 minute
Secondary outcomes (1)
Re-bleeding
Number of participants who experience decrease in hemoglobin >1g/dl or need additional hemostatic endoscopy within one week after intervention
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start1 Mar 2021
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro Intestinal BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Cipto Mangunkusumo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan Maulahela, MD, Dr Cipto Mangunkusumo General Hospital
- Investigators
- Hasan Maulahela, MD, Principal investigator, Dr Cipto Mangunkusumo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04979273
- Sponsor's protocol ID
- 20-02-0130
- Status last verified
- Jul 2021
- First submitted
- 2 Jul 2021
- Last updated
- 28 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Hypertonic Dextrose Spray as Endoscopic Topical Hemostatic Agent for Acute Non-Variceal Upper Gastrointestinal Bleeding: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04979273
- Acronym / sponsor ID
- 20-02-0130
- Conditions
- Gastro Intestinal Bleeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Dr Cipto Mangunkusumo General HospitalUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 28 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Drug: Adrenaline 1 Mg/mL Solution for Injection, Procedure: argon plasma coagulation, Procedure: HemoclipPatients within control group will be given adrenaline 1:20.000 injection, followed by thermocoagulation or hemoclip |
| Dextrose group | Experimental | Drug: Dextrose 40 % in Water, Drug: Adrenaline 1 Mg/mL Solution for InjectionPatients within this group will be given adrenaline 1:20.000 injection, followed by dextrose 40% spray |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with acute non-variceal upper gastrointestinal bleeding caused by peptic or duodenal ulcer, polyps, tumors or malignancy
- Patients consented to study participation
Key exclusion criteria (1 listed)
- Patients with thrombocytopenia (thrombocyte count <100.000 cells/ul) and other forms of coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dextrose 40 % in Waterinjection of adrenaline 1:20.000, followed by dextrose 40% spray | Drug | Dextrose group |
| Adrenaline 1 Mg/mL Solution for Injectioninjection of adrenaline 1:20.000, followed by thermocoagulation or hemoclip | Drug | Control Group, Dextrose group |
| argon plasma coagulationThermocoagulation | Procedure or surgery | Control Group |
| HemoclipHemoclip | Procedure or surgery | Control Group |
Primary outcome
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.
1 secondary outcome
Re-bleeding
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hasan Maulahela, MD principal investigator
Dr Cipto Mangunkusumo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dextrose 40 % in Water, Adrenaline 1 Mg/mL Solution for Injection and argon plasma coagulation in people with Gastro Intestinal Bleeding, run by Dr Cipto Mangunkusumo General Hospital at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hasan Maulahela, MD (+6281283602549, hasanmaulahela@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemostatic success (time frame: 5 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.