Back to resultsNew Technologies for Endoscopic Treatment of Bleeding Gastroduodenal Ulcers
Primary Purpose
Ulcer Hemorrhage
Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Complex endoscopic treatment with the use of granular sorbent aseptisorb-A and autoplasm enriched with platelets
Traditional methods of endoscopic hemostasis
Sponsored by
About this trial
This is an interventional treatment trial for Ulcer Hemorrhage focused on measuring ulcer, bleeding, treatment, aseptisorb-A
Eligibility Criteria
Inclusion Criteria:
- Gastroduodenal ulcers with bleeding
Exclusion Criteria:
- Bleedings of other etiology
Sites / Locations
- Voronezh State Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Applications of autoplasma, enriched with platelets and
Traditional methods of endoscopic hemostasis
Arm Description
Endoscopic applications of autoplasma, enriched with platelets and granular sorbent aseptisorb-A in bleeding gastroduodenal ulcers
Traditional methods of endoscopic hemostasis were used without the use of platelet-enriched plasma and granular sorbents.
Outcomes
Primary Outcome Measures
the timing of final hemostasis
the timing of final hemostasis
Secondary Outcome Measures
the frequency of recurrent bleeding
the frequency of recurrent bleeding
mortality rates
mortality rates
healing of ulcerative defects
sizes of ulcerative defects
Full Information
NCT ID
NCT04239118
First Posted
January 19, 2020
Last Updated
January 19, 2020
Sponsor
Voronezh N.N. Burdenko State Medical Academy
1. Study Identification
Unique Protocol Identification Number
NCT04239118
Brief Title
New Technologies for Endoscopic Treatment of Bleeding Gastroduodenal Ulcers
Official Title
New Technologies for Endoscopic Treatment of Bleeding Gastroduodenal Ulcers
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 10, 2018 (Actual)
Primary Completion Date
June 16, 2019 (Actual)
Study Completion Date
December 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Voronezh N.N. Burdenko State Medical Academy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcer Hemorrhage
Keywords
ulcer, bleeding, treatment, aseptisorb-A
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Applications of autoplasma, enriched with platelets and
Arm Type
Experimental
Arm Description
Endoscopic applications of autoplasma, enriched with platelets and granular sorbent aseptisorb-A in bleeding gastroduodenal ulcers
Arm Title
Traditional methods of endoscopic hemostasis
Arm Type
Other
Arm Description
Traditional methods of endoscopic hemostasis were used without the use of platelet-enriched plasma and granular sorbents.
Intervention Type
Combination Product
Intervention Name(s)
Complex endoscopic treatment with the use of granular sorbent aseptisorb-A and autoplasm enriched with platelets
Intervention Description
Complex endoscopic bleeding ulcers treatment with the use of granular sorbent aseptisorb-A and autoplasm enriched with platelets
Intervention Type
Procedure
Intervention Name(s)
Traditional methods of endoscopic hemostasis
Intervention Description
Traditional methods of endoscopic hemostasis were used without the use of platelet-enriched plasma and granular sorbents
Primary Outcome Measure Information:
Title
the timing of final hemostasis
Description
the timing of final hemostasis
Time Frame
a week
Secondary Outcome Measure Information:
Title
the frequency of recurrent bleeding
Description
the frequency of recurrent bleeding
Time Frame
1 year
Title
mortality rates
Description
mortality rates
Time Frame
1 year
Title
healing of ulcerative defects
Description
sizes of ulcerative defects
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
44 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Gastroduodenal ulcers with bleeding
Exclusion Criteria:
Bleedings of other etiology
Facility Information:
Facility Name
Voronezh State Medical University
City
Voronezh
ZIP/Postal Code
394019
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
New Technologies for Endoscopic Treatment of Bleeding Gastroduodenal Ulcers
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