NCT04239118

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 19, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 23, 2020

Completed
Last Updated

January 23, 2020

Status Verified

January 1, 2020

Enrollment Period

1.4 years

First QC Date

January 19, 2020

Last Update Submit

January 19, 2020

Conditions

Ulcer Hemorrhage

Keywords

ulcerbleedingtreatmentaseptisorb-A

Outcome Measures

Primary Outcomes (1)

  • the timing of final hemostasis

    the timing of final hemostasis

    a week

Secondary Outcomes (3)

  • the frequency of recurrent bleeding

    1 year

  • mortality rates

    1 year

  • healing of ulcerative defects

    1 year

Study Arms (2)

Applications of autoplasma, enriched with platelets and

EXPERIMENTAL

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

Traditional methods of endoscopic hemostasis

OTHER

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

Procedure: Traditional methods of endoscopic hemostasis

Interventions

Complex endoscopic treatment with the use of granular sorbent aseptisorb-A and autoplasm enriched with plateletsCOMBINATION_PRODUCT

Complex endoscopic bleeding ulcers treatment with the use of granular sorbent aseptisorb-A and autoplasm enriched with platelets

Applications of autoplasma, enriched with platelets and
Traditional methods of endoscopic hemostasisPROCEDURE

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

Traditional methods of endoscopic hemostasis

Eligibility Criteria

Age44 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Gastroduodenal ulcers with bleeding

You may not qualify if:

  • Bleedings of other etiology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Voronezh State Medical University

Voronezh, 394019, Russia

Location

MeSH Terms

Conditions

UlcerHemorrhage

Interventions

Platelet Count

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Cell CountCell CountCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHematologic TestsPlatelet Function TestsInvestigative TechniquesCell Physiological PhenomenaBlood Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2020

First Posted

January 23, 2020

Study Start

January 10, 2018

Primary Completion

June 16, 2019

Study Completion

December 20, 2019

Last Updated

January 23, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)