New Technologies for Endoscopic Treatment of Bleeding Gastroduodenal Ulcers

Not Applicable

Completed

• Conditions: Ulcer Hemorrhage
• Interventions: Combination Product: Complex endoscopic treatment with the use of granular sorbent aseptisorb-A and autoplasm enriched with platelets; Procedure: Traditional methods of endoscopic hemostasis

• Registration Number: NCT04239118
• Lead Sponsor: Voronezh N.N. Burdenko State Medical Academy

Brief 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.

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 Timeline

• Study Start: 2018-01-10
• Primary Completion: 2019-06-16
• Study Completion: 2019-12-20
• Status Verified: 2020-01
• Study First Submitted: 2020-01-19
• Study First Submitted QC: 2020-01-19
• Last Update Submitted: 2020-01-19
• Study First Posted: 2020-01-23
• Last Update Posted: 2020-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

• Gastroduodenal ulcers with bleeding

Exclusion Criteria

• Bleedings of other etiology

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Applications of autoplasma, enriched with platelets and	Complex endoscopic treatment with the use of granular sorbent aseptisorb-A and autoplasm enriched with platelets	Endoscopic applications of autoplasma, enriched with platelets and granular sorbent aseptisorb-A in bleeding gastroduodenal ulcers
Traditional methods of endoscopic hemostasis	Traditional methods of endoscopic hemostasis	Traditional methods of endoscopic hemostasis were used without the use of platelet-enriched plasma and granular sorbents.

Primary Outcome Measures

Name	Time	Method
the timing of final hemostasis	a week	the timing of final hemostasis

Secondary Outcome Measures

Name	Time	Method
healing of ulcerative defects	1 year	sizes of ulcerative defects
the frequency of recurrent bleeding	1 year	the frequency of recurrent bleeding
mortality rates	1 year	mortality rates

Trial Locations

Locations (1)

Voronezh State Medical University; 🇷🇺 Voronezh, Russian Federation