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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Applications of autoplasma, enriched with platelets and | Experimental | Endoscopic applications of autoplasma, enriched with platelets and granular sorbent aseptisorb-A in bleeding gastroduodenal ulcers |
|
| Traditional methods of endoscopic hemostasis | Other | Traditional methods of endoscopic hemostasis were used without the use of platelet-enriched plasma and granular sorbents. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Complex endoscopic treatment with the use of granular sorbent aseptisorb-A and autoplasm enriched with platelets | Combination Product | Complex endoscopic bleeding ulcers treatment with the use of granular sorbent aseptisorb-A and autoplasm enriched with platelets |
| Measure | Description | Time Frame |
|---|---|---|
| the timing of final hemostasis | the timing of final hemostasis | a week |
| Measure | Description | Time Frame |
|---|---|---|
| the frequency of recurrent bleeding | the frequency of recurrent bleeding | 1 year |
| mortality rates | mortality rates | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Voronezh State Medical University | Voronezh | 394019 | Russia |
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| Traditional methods of endoscopic hemostasis | Procedure | Traditional methods of endoscopic hemostasis were used without the use of platelet-enriched plasma and granular sorbents |
|
| healing of ulcerative defects | sizes of ulcerative defects | 1 year |
| ID | Term |
|---|---|
| D014456 | Ulcer |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010976 | Platelet Count |
| ID | Term |
|---|---|
| D001772 | Blood Cell Count |
| D002452 | Cell Count |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006403 | Hematologic Tests |
| D010979 | Platelet Function Tests |
| D008919 | Investigative Techniques |
| D002468 | Cell Physiological Phenomena |
| D001790 | Blood Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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