COVID-19 (Coronavirus Disease 2019)NCT06223945
Thrombohemorrhagic Complications of COVID-19
A study testing Prevention algorithm in people with COVID-19 (Coronavirus Disease 2019), run by Volgograd State Medical University at 1 site in Russia.
Trial summary
The nature of the planned study: The topic is of an applied nature and is aimed at improving the results of comprehensive treatment of patients with COVID-19, the course of whose disease was complicated by thrombotic or hemorrhagic catastrophes. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- COVID-19 (Coronavirus Disease 2019)
- What is being tested?
- Prevention algorithm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteRussia
- Study dates
- 12 Jan 2024to 12 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with thrombohemorrhagic complications who were treated in a covid hospital
Who cannot join
- Cancer patients
- Patients who had thrombohemorrhagic disorders before admission to the hospital
- Pregnant women
- Patients receiving routine anticoagulant and antiplatelet therapy before admission to the hospital
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgical and Anesthesiological-resuscitation Aspects of Therapeutic Tactics for Thrombotic and Hemorrhagic Complications in Patients With the New Coronavirus Infection COVID-19
The nature of the planned study:
The topic is of an applied nature and is aimed at improving the results of comprehensive treatment of patients with COVID-19, the course of whose disease was complicated by thrombotic or hemorrhagic catastrophes.
Read more
It is planned to analyze the results of treatment of this category of patients based on the work of several centers that provided surgical care to patients with COVID-19 during the pandemic (8 cities).
As a result of the analysis, it is planned to develop algorithms for the prevention and treatment of thrombotic and hemorrhagic complications in patients with COVID-19.
The proposed study will be multicenter, cohort, retrospective.
The purpose of the study:
Improvement of treatment results in COVID-19 patients with thrombotic or hemorrhagic complications
Scientific novelty:
For the first time, as a result of a multicenter study, it is expected to identify the most effective approach to the treatment and prevention of thrombotic and hemorrhagic complications in patients with COVID-19.
For the first time, it is planned to develop and put into practice algorithms for the application of the most effective methods of treatment and prevention of thrombohemorrhagic complications of COVID-19.
- Conditions
- COVID-19 (Coronavirus Disease 2019)
- Being tested
- Prevention algorithm
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevention algorithmDiagnostic test
Development of an algorithm for the prevention of thrombohemorrhagic complications
| Study group | Role | What they receive |
|---|---|---|
| Thrombotic and hemorrhagic complications of COVID-19 | Active comparator | Not described Receives: Diagnostic Test: Prevention algorithm |
| Prevention of thrombohemorrhagic complications in COVID-19 | Active comparator | Not described Receives: Diagnostic Test: Prevention algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
development of an algorithm for the prevention of thrombohemorrhagic complications of COVID-19
It is planned to perform a multicenter cohort retrospective study with an expanded analysis of the clinical features of the course, the results of surgical treatment, intensive care, anesthesiological and resuscitation benefits in patients with COVID-19, the course of which was complicated by thrombotic and hemorrhagic complications, including internal and external bleeding from the hollow organs of the abdominal cavity, retroperitoneal space and chest. The material for the study will be formed by combining data from several large clinics, on the basis of which infectious diseases hospitals with a concentration of surgical patients have been deployed. Based on the cumulative assessment of the results obtained, new and improved previously developed surgical and anesthetic-resuscitation algorithms for diagnosis, surgical tactics, intensive care in patients with COVID-19 with thrombotic and hemorrhagic complications in need of surgical and resuscitation procedures will be proposed.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start12 Jan 2024
- Primary completion12 Jan 2029 (estimated)
- Study completion12 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 (Coronavirus Disease 2019)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Volgograd State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Viktor Mikhin, Study chair, Volgograd State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06223945
- Sponsor's protocol ID
- 12/2024/01/12
- Status last verified
- Jan 2024
- First submitted
- 22 Jan 2024
- Last updated
- 25 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical and Anesthesiological-resuscitation Aspects of Therapeutic Tactics for Thrombotic and Hemorrhagic Complications in Patients With the New Coronavirus Infection COVID-19
- ClinicalTrials.gov ID
- NCT06223945
- Acronym / sponsor ID
- 12/2024/01/12
- Conditions
- COVID-19 (Coronavirus Disease 2019)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Volgograd State Medical UniversityUniversity, hospital or other
- Study start
- 12 Jan 2024 (actual)
- Primary completion
- 12 Jan 2029 (estimated)
- Study completion
- 12 Jan 2029 (estimated)
- First posted
- 25 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The nature of the planned study:
The topic is of an applied nature and is aimed at improving the results of comprehensive treatment of patients with COVID-19, the course of whose disease was complicated by thrombotic or hemorrhagic catastrophes.
It is planned to analyze the results of treatment of this category of patients based on the work of several centers that provided surgical care to patients with COVID-19 during the pandemic (8 cities).
As a result of the analysis, it is planned to develop algorithms for the prevention and treatment of thrombotic and hemorrhagic complications in patients with COVID-19.
The proposed study will be multicenter, cohort, retrospective.
The purpose of the study:
Improvement of treatment results in COVID-19 patients with thrombotic or hemorrhagic complications
Scientific novelty:
For the first time, as a result of a multicenter study, it is expected to identify the most effective approach to the treatment and prevention of thrombotic and hemorrhagic complications in patients with COVID-19.
For the first time, it is planned to develop and put into practice algorithms for the application of the most effective methods of treatment and prevention of thrombohemorrhagic complications of COVID-19.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thrombotic and hemorrhagic complications of COVID-19 | Active comparator | Diagnostic Test: Prevention algorithm |
| Prevention of thrombohemorrhagic complications in COVID-19 | Active comparator | Diagnostic Test: Prevention algorithm |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with thrombohemorrhagic complications who were treated in a covid hospital
Key exclusion criteria (4 listed)
- Cancer patients
- Patients who had thrombohemorrhagic disorders before admission to the hospital
- Pregnant women
- Patients receiving routine anticoagulant and antiplatelet therapy before admission to the hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prevention algorithmDevelopment of an algorithm for the prevention of thrombohemorrhagic complications | Diagnostic test | Prevention of thrombohemorrhagic complications in COVID-19, Thrombotic and hemorrhagic complications of COVID-19 |
Primary outcome
development of an algorithm for the prevention of thrombohemorrhagic complications of COVID-19
Time frame: 5 years
It is planned to perform a multicenter cohort retrospective study with an expanded analysis of the clinical features of the course, the results of surgical treatment, intensive care, anesthesiological and resuscitation benefits in patients with COVID-19, the course of which was complicated by thrombotic and hemorrhagic complications, including internal and external bleeding from the hollow organs of the abdominal cavity, retroperitoneal space and chest. The material for the study will be formed by combining data from several large clinics, on the basis of which infectious diseases hospitals with a concentration of surgical patients have been deployed. Based on the cumulative assessment of the results obtained, new and improved previously developed surgical and anesthetic-resuscitation algorithms for diagnosis, surgical tactics, intensive care in patients with COVID-19 with thrombotic and hemorrhagic complications in need of surgical and resuscitation procedures will be proposed.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Viktor Mikhin study chair
Volgograd State Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prevention algorithm in people with COVID-19 (Coronavirus Disease 2019), run by Volgograd State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
development of an algorithm for the prevention of thrombohemorrhagic complications of COVID-19 (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2024.