New Technologies for Endoscopic Treatment of Bleeding Gastroduodenal Ulcers

Voronezh N.N. Burdenko State Medical Academy

Status: Completed

Conditions: Ulcer Hemorrhage

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04239118

Cherednikov

Details and patient eligibility

About

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.

Full 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.

Enrollment: 112 patients

Sex: All

Ages: 44 to 67 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Gastroduodenal ulcers with bleeding

Exclusion criteria

• Bleedings of other etiology

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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112 participants in 2 patient groups

Applications of autoplasma, enriched with platelets and

Experimental group

Description:

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

Treatment:

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

Traditional methods of endoscopic hemostasis

Other group

Description:

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

Treatment:

Procedure: Traditional methods of endoscopic hemostasis