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New Technologies for Endoscopic Treatment of Bleeding Gastroduodenal Ulcers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04239118
Recruitment Status : Completed
First Posted : January 23, 2020
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
Voronezh N.N. Burdenko State Medical Academy

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : January 10, 2018
Actual Primary Completion Date : June 16, 2019
Actual Study Completion Date : December 20, 2019

Resource links provided by the National Library of Medicine


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

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




Primary Outcome Measures :
  1. the timing of final hemostasis [ Time Frame: a week ]
    the timing of final hemostasis


Secondary Outcome Measures :
  1. the frequency of recurrent bleeding [ Time Frame: 1 year ]
    the frequency of recurrent bleeding

  2. mortality rates [ Time Frame: 1 year ]
    mortality rates

  3. healing of ulcerative defects [ Time Frame: 1 year ]
    sizes of ulcerative defects



Information from the National Library of Medicine

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Ages Eligible for Study:   44 Years to 67 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Gastroduodenal ulcers with bleeding

Exclusion Criteria:

  • Bleedings of other etiology

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04239118


Locations
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Russian Federation
Voronezh State Medical University
Voronezh, Russian Federation, 394019
Sponsors and Collaborators
Voronezh N.N. Burdenko State Medical Academy

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Responsible Party: Voronezh N.N. Burdenko State Medical Academy
ClinicalTrials.gov Identifier: NCT04239118    
Other Study ID Numbers: Cherednikov
First Posted: January 23, 2020    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Voronezh N.N. Burdenko State Medical Academy:
ulcer
bleeding
treatment
aseptisorb-A
Additional relevant MeSH terms:
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Peptic Ulcer
Ulcer
Hemorrhage
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Hemostatics
Coagulants