New Technologies for Endoscopic Treatment of Bleeding Gastroduodenal Ulcers

NCT ID: NCT04239118

Last Updated: 2020-01-23

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-10

Study Completion Date

2019-12-20

Brief Summary

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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

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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

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Ulcer Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Applications of autoplasma, enriched with platelets and

Endoscopic applications of autoplasma, enriched with platelets and granular sorbent aseptisorb-A in bleeding gastroduodenal ulcers

Group Type EXPERIMENTAL

Complex endoscopic treatment with the use of granular sorbent aseptisorb-A and autoplasm enriched with platelets

Intervention Type COMBINATION_PRODUCT

Complex endoscopic bleeding ulcers treatment with the use of granular sorbent aseptisorb-A and autoplasm enriched with platelets

Traditional methods of endoscopic hemostasis

Traditional methods of endoscopic hemostasis were used without the use of platelet-enriched plasma and granular sorbents.

Group Type OTHER

Traditional methods of endoscopic hemostasis

Intervention Type PROCEDURE

Traditional methods of endoscopic hemostasis were used without the use of platelet-enriched plasma and granular sorbents

Interventions

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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

Intervention Type COMBINATION_PRODUCT

Traditional methods of endoscopic hemostasis

Traditional methods of endoscopic hemostasis were used without the use of platelet-enriched plasma and granular sorbents

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Gastroduodenal ulcers with bleeding

Exclusion Criteria

* Bleedings of other etiology
Minimum Eligible Age

44 Years

Maximum Eligible Age

67 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Voronezh N.N. Burdenko State Medical Academy

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Voronezh State Medical University

Voronezh, , Russia

Site Status

Countries

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Russia

Other Identifiers

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Cherednikov

Identifier Type: -

Identifier Source: org_study_id

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