New Technologies for Endoscopic Treatment of Bleeding Gastroduodenal Ulcers

Study Overview
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Brief Summary
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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
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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.

Official Title
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New Technologies for Endoscopic Treatment of Bleeding Gastroduodenal Ulcers

Conditions
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Ulcer Hemorrhage

Intervention / Treatment
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* Combination Product: Complex endoscopic treatment with the use of granular sorbent aseptisorb-A and autoplasm enriched with platelets
* Procedure: Traditional methods of endoscopic hemostasis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gastroduodenal ulcers with bleeding Exclusion Criteria: Bleedings of other etiology

Ages Eligible for Study
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Minimum Age: 44 Years
Maximum Age: 67 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Applications of autoplasma, enriched with platelets and<br>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<br>* Complex endoscopic bleeding ulcers treatment with the use of granular sorbent aseptisorb-A and autoplasm enriched with platelets<br>|
| Other: Traditional methods of endoscopic hemostasis<br>Traditional methods of endoscopic hemostasis were used without the use of platelet-enriched plasma and granular sorbents. | Procedure: Traditional methods of endoscopic hemostasis<br>* Traditional methods of endoscopic hemostasis were used without the use of platelet-enriched plasma and granular sorbents<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the timing of final hemostasis | the timing of final hemostasis | a week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the frequency of recurrent bleeding | the frequency of recurrent bleeding | 1 year | 
| mortality rates | mortality rates | 1 year | 
| healing of ulcerative defects | sizes of ulcerative defects | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ulcer, bleeding, treatment, aseptisorb-A