New Technologies for Endoscopic Treatment of Bleeding Gastroduodenal Ulcers

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04239118

Enrollment

112

Registered

2020-01-23

Start date

2018-01-10

Completion date

2019-12-20

Last updated

2020-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcer Hemorrhage

Keywords

ulcer, bleeding, treatment, aseptisorb-A

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.

Interventions

COMBINATION_PRODUCTComplex 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

PROCEDURETraditional methods of endoscopic hemostasis

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

44 Years to 67 Years

Healthy volunteers

Inclusion criteria

* Gastroduodenal ulcers with bleeding

Exclusion criteria

* Bleedings of other etiology

Design outcomes

Primary

Measure	Time frame	Description
the timing of final hemostasis	a week	the timing of final hemostasis

Secondary

Measure	Time frame	Description
the frequency of recurrent bleeding	1 year	the frequency of recurrent bleeding
mortality rates	1 year	mortality rates
healing of ulcerative defects	1 year	sizes of ulcerative defects

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026