New Technologies for Endoscopic Treatment of Bleeding Gastroduodenal Ulcers

Sponsor

Voronezh N.N. Burdenko State Medical Academy (Other)

Overall Status

Completed

CT.gov ID

NCT04239118

Collaborator

(none)

112

Enrollment

Location

Arms

23.3

Actual Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ulcer Hemorrhage	Combination Product: Complex endoscopic treatment with the use of granular sorbent aseptisorb-A and autoplasm enriched with platelets Procedure: Traditional methods of endoscopic hemostasis	N/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 Design

Study Type:

Interventional

Actual Enrollment :

112 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

New Technologies for Endoscopic Treatment of Bleeding Gastroduodenal Ulcers

Actual Study Start Date :

Jan 10, 2018

Actual Primary Completion Date :

Jun 16, 2019

Actual Study Completion Date :

Dec 20, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Applications of autoplasma, enriched with platelets and Endoscopic applications of autoplasma, enriched with platelets and granular sorbent aseptisorb-A in bleeding gastroduodenal ulcers	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
Other: Traditional methods of endoscopic hemostasis Traditional methods of endoscopic hemostasis were used without the use of platelet-enriched plasma and granular sorbents.	Procedure: Traditional methods of endoscopic hemostasis Traditional methods of endoscopic hemostasis were used without the use of platelet-enriched plasma and granular sorbents

Arm

Intervention/Treatment

Experimental: Applications of autoplasma, enriched with platelets and

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

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

Other: Traditional methods of endoscopic hemostasis

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

Procedure: Traditional methods of endoscopic hemostasis

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

Outcome Measures

Primary Outcome Measures

the timing of final hemostasis [a week]
the timing of final hemostasis

Secondary Outcome Measures

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