Ulcer HemorrhageNCT04239118
New Technologies for Endoscopic Treatment of Bleeding Gastroduodenal Ulcers
A study testing Complex endoscopic treatment with the use of granular sorbent aseptisorb-A and autoplasm enriched with platelets and Traditional methods of endoscopic hemostasis in people with Ulcer Hemorrhage, run by Voronezh N.N. Burdenko State Medical Academy at 1 site in Russia.
Trial summary
The purpose of the study was to improve treatment results of patients with bleeding gastroduodenal ulcers by endoscopic applications of autoplasma, enriched with platelets and granular sorbent aseptisorb-A. Read more about this study
- Who is it for?
- Ages 44 to 67 years
- Conditions the study is for
- Ulcer Hemorrhage
- What is being tested?
- Complex endoscopic treatment with the use of granular sorbent aseptisorb-A and autoplasm enriched with platelets and Traditional methods of endoscopic hemostasis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteRussia
- Study dates
- 10 Jan 2018to 20 Dec 2019
- 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 44 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gastroduodenal ulcers with bleeding
Who cannot join
- Bleedings of other etiology
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study was to improve treatment results of patients with bleeding gastroduodenal ulcers by endoscopic applications of autoplasma, enriched with platelets and granular sorbent aseptisorb-A.
Read the detailed description
The clinical study was conducted on the basis of the Voronezh city specialized Center for the treatment of patients with gastrointestinal bleeding. The study included 112 patients with ulcerative gastroduodenal bleeding. All patients were divided into two groups by random sampling: the main group (n=57 people) and the comparison group (n=55 people). In the treatment of patients of the main group (57 people), an individual approach was used with the use of granular sorbent aseptisorb-A and autoplasm enriched with platelets, in the complex endoscopic treatment of bleeding-complicated gastroduodenal ulcers (Patent Russian Federation (RF) № 2632771). In the comparison group (55 people), traditional methods of endoscopic hemostasis were used.
- Conditions
- Ulcer Hemorrhage
- Being tested
- Complex endoscopic treatment with the use of granular sorbent aseptisorb-A and autoplasm enriched with platelets, Traditional methods of endoscopic hemostasis
- Keywords
- ulcer, bleeding, treatment, aseptisorb-A
- Medical subject headings
- Ulcer, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complex endoscopic treatment with the use of granular sorbent aseptisorb-A and autoplasm enriched with plateletsCombination product
Complex endoscopic bleeding ulcers treatment with the use of granular sorbent aseptisorb-A and autoplasm enriched with platelets
Traditional methods of endoscopic hemostasisProcedure or surgery
Traditional methods of endoscopic hemostasis were used without the use of platelet-enriched plasma and granular sorbents
| Study group | Role | What they receive |
|---|---|---|
| Applications of autoplasma, enriched with platelets and | Experimental | Endoscopic applications of autoplasma, enriched with platelets and granular sorbent aseptisorb-A in bleeding gastroduodenal ulcers Receives: Combination Product: Complex endoscopic treatment with the use of granular sorbent aseptisorb-A and autoplasm enriched with platelets |
| Traditional methods of endoscopic hemostasis | Other | Traditional methods of endoscopic hemostasis were used without the use of platelet-enriched plasma and granular sorbents. Receives: Procedure: Traditional methods of endoscopic hemostasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
the timing of final hemostasis
the timing of final hemostasis
Measured: a week
Secondary outcomes (3)
the frequency of recurrent bleeding
the frequency of recurrent bleeding
Measured: 1 year
mortality rates
mortality rates
Measured: 1 year
healing of ulcerative defects
sizes of ulcerative defects
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start10 Jan 2018
- Primary completion16 Jun 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcer HemorrhageStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Voronezh N.N. Burdenko State Medical Academy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04239118
- Sponsor's protocol ID
- Cherednikov
- Status last verified
- Jan 2020
- First submitted
- 19 Jan 2020
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Technologies for Endoscopic Treatment of Bleeding Gastroduodenal Ulcers
- ClinicalTrials.gov ID
- NCT04239118
- Acronym / sponsor ID
- Cherednikov
- Conditions
- Ulcer Hemorrhage
- Keywords
- ulcer, bleeding, treatment, aseptisorb-A
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Voronezh N.N. Burdenko State Medical AcademyUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 16 Jun 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 23 Jan 2020 (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.
The purpose of the study was to improve treatment results of patients with bleeding gastroduodenal ulcers by endoscopic applications of autoplasma, enriched with platelets and granular sorbent aseptisorb-A.
Detailed description
The clinical study was conducted on the basis of the Voronezh city specialized Center for the treatment of patients with gastrointestinal bleeding. The study included 112 patients with ulcerative gastroduodenal bleeding. All patients were divided into two groups by random sampling: the main group (n=57 people) and the comparison group (n=55 people). In the treatment of patients of the main group (57 people), an individual approach was used with the use of granular sorbent aseptisorb-A and autoplasm enriched with platelets, in the complex endoscopic treatment of bleeding-complicated gastroduodenal ulcers (Patent Russian Federation (RF) № 2632771). In the comparison group (55 people), traditional methods of endoscopic hemostasis were used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Applications of autoplasma, enriched with platelets and | Experimental | Combination Product: Complex endoscopic treatment with the use of granular sorbent aseptisorb-A and autoplasm enriched with plateletsEndoscopic applications of autoplasma, enriched with platelets and granular sorbent aseptisorb-A in bleeding gastroduodenal ulcers |
| Traditional methods of endoscopic hemostasis | Other | Procedure: Traditional methods of endoscopic hemostasisTraditional methods of endoscopic hemostasis were used without the use of platelet-enriched plasma and granular sorbents. |
Who may qualify
- Ages
- 44 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Gastroduodenal ulcers with bleeding
Key exclusion criteria (1 listed)
- Bleedings of other etiology
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 |
|---|---|---|
| Complex endoscopic treatment with the use of granular sorbent aseptisorb-A and autoplasm enriched with plateletsComplex endoscopic bleeding ulcers treatment with the use of granular sorbent aseptisorb-A and autoplasm enriched with platelets | Combination product | Applications of autoplasma, enriched with platelets and |
| Traditional methods of endoscopic hemostasisTraditional methods of endoscopic hemostasis were used without the use of platelet-enriched plasma and granular sorbents | Procedure or surgery | Traditional methods of endoscopic hemostasis |
Primary outcome
the timing of final hemostasis
Time frame: a week
the timing of final hemostasis
3 secondary outcomes
the frequency of recurrent bleeding
Time frame: 1 year
mortality rates
Time frame: 1 year
healing of ulcerative defects
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complex endoscopic treatment with the use of granular sorbent aseptisorb-A and autoplasm enriched with platelets and Traditional methods of endoscopic hemostasis in people with Ulcer Hemorrhage, run by Voronezh N.N. Burdenko State Medical Academy at 1 site in Russia.
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 1 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: finished, as of the sponsor's last update on 23 Jan 2020. 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 Russia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the timing of final hemostasis (time frame: a week). 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 23 Jan 2020.