New Technologies for Endoscopic Treatment of Bleeding Gastroduodenal Ulcers

Ulcer Hemorrhage Clinical Trial

Official title:

New Technologies for Endoscopic Treatment of Bleeding Gastroduodenal Ulcers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04239118
• Other study ID #: Cherednikov
• Status: Completed
• Phase: N/A
• Start date: January 10, 2018
• Est. completion date: December 20, 2019

Study information

• Verified date: January 2020
• Source: Voronezh N.N. Burdenko State Medical Academy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: December 20, 2019
• Est. primary completion date: June 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 44 Years to 67 Years

Eligibility

Inclusion Criteria:

• Gastroduodenal ulcers with bleeding

Exclusion Criteria:

• Bleedings of other etiology

Related Conditions & MeSH terms

• Hemorrhage
• Peptic Ulcer
• Ulcer
• Ulcer Hemorrhage

Intervention

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

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

Locations

Country	Name	City	State
Russian Federation	Voronezh State Medical University	Voronezh

Sponsors (1)

Lead Sponsor	Collaborator
Voronezh N.N. Burdenko State Medical Academy

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the timing of final hemostasis	the timing of final hemostasis	a week
Secondary	the frequency of recurrent bleeding	the frequency of recurrent bleeding	1 year
Secondary	mortality rates	mortality rates	1 year
Secondary	healing of ulcerative defects	sizes of ulcerative defects	1 year