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Completed

NCT Number: NCT04239118

New Technologies for Endoscopic Treatment of Bleeding Gastroduodenal Ulcers

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.

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Key information

Conditions

Ulcer Hemorrhage Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Ulcer

Age range

44 year–67 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Voronezh State Medical University

Voronezh, 394019, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Gastroduodenal ulcers with bleeding

Exclusion criteria

  • Bleedings of other etiology

Treatment and study plan

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

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

Procedure

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

Primary outcomes

  1. the timing of final hemostasis

    Time frame: a week

    the timing of final hemostasis

Secondary outcomes

  1. the frequency of recurrent bleeding

    Time frame: 1 year

    the frequency of recurrent bleeding

  2. mortality rates

    Time frame: 1 year

    mortality rates

  3. healing of ulcerative defects

    Time frame: 1 year

    sizes of ulcerative defects

Sponsors and collaborators

Lead sponsor

Voronezh N.N. Burdenko State Medical Academy

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 23, 2020
Registry last updated
Jan 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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