New Technologies for Endoscopic Treatment of Bleeding Gastroduodenal Ulcers

January 19, 2020 updated by: Voronezh N.N. Burdenko State Medical Academy
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

112

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 Locations

  • Russian Federation
      • Voronezh, Russian Federation, 394019
        • Voronezh State Medical University

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

44 years to 67 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Gastroduodenal ulcers with bleeding

Exclusion Criteria:

  • Bleedings of other etiology

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Applications of autoplasma, enriched with platelets and
Endoscopic applications of autoplasma, enriched with platelets and granular sorbent aseptisorb-A in bleeding gastroduodenal ulcers
Combination product: Complex endoscopic treatment with the use of granular sorbent aseptisorb-A and autoplasm enriched with platelets
Complex endoscopic bleeding ulcers treatment with the use of granular sorbent aseptisorb-A and autoplasm enriched with platelets
Other: Traditional methods of endoscopic hemostasis
Traditional methods of endoscopic hemostasis were used without the use of platelet-enriched plasma and granular sorbents.
Procedure: Traditional methods of endoscopic hemostasis
Traditional methods of endoscopic hemostasis were used without the use of platelet-enriched plasma and granular sorbents

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the timing of final hemostasis
Time Frame: a week
the timing of final hemostasis
a week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the frequency of recurrent bleeding
Time Frame: 1 year
the frequency of recurrent bleeding
1 year
mortality rates
Time Frame: 1 year
mortality rates
1 year
healing of ulcerative defects
Time Frame: 1 year
sizes of ulcerative defects
1 year

Collaborators and Investigators

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

Sponsor

Voronezh N.N. Burdenko State Medical Academy

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)

January 10, 2018

Primary Completion (Actual)

June 16, 2019

Study Completion (Actual)

December 20, 2019

Study Registration Dates

First Submitted

January 19, 2020

First Submitted That Met QC Criteria

January 19, 2020

First Posted (Actual)

January 23, 2020

Study Record Updates

Last Update Posted (Actual)

January 23, 2020

Last Update Submitted That Met QC Criteria

January 19, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cherednikov

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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