Aortic SurgeryNCT05171023
Application of ROTEM Technology in Aortic Surgery
An observational study of Aortic Surgery and Coagulation Management, run by Petrovsky National Research Centre of Surgery at 1 site in Russia.
Trial summary
Comparison of the diagnostic capabilities of rotational thromboelastometry (ROTEM) and standard coagulogram in the detection of disorder and correction of the hemostasis system in the perioperative period in patients who underwent surgical intervention on the aorta under cardiopulmonary bypass and or circulatory… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aortic Surgery, Coagulation Management
- What is being tested?
- ROTEM and standard coagulation tests
- Type of treatment
- Medical device
- How many people
- 81 participants
- Where
- 1 siteRussia
- Study dates
- 1 Nov 2021to 25 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients after surgical interventions on the aorta with cardiopulmonary bypass and/or circulatory arrest.
Who may be able to join
- Age from 18 to 80 years.
- Patients after surgical interventions on the aorta with cardiopulmonary bypass and/or circulatory arrest (operations on the ascending aorta, aortic arch and thoracoabdominal aorta).
Who cannot join
- Patients with other cardiac surgery, including isolated endovascular interventions on the aorta.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of ROTEM Technology in Aortic Surgery Under Cardiopulmonary Bypass and Circulatory Arrest
Comparison of the diagnostic capabilities of rotational thromboelastometry (ROTEM) and standard coagulogram in the detection of disorder and correction of the hemostasis system in the perioperative period in patients who underwent surgical intervention on the aorta under cardiopulmonary bypass and or circulatory arrest.
Read the detailed description
The patient is monitored in the intensive care unit according to the following scheme: ROTEM (NATEM, INTEM, EXTEM, FIBTEM; with high clotting time (CT) values in INTEM - HEPTEM is done) and a coagulogram (activated coagulation time (ACT), activated partial thromboplastin time (APTT), prothrombin time (PT), thrombin time (TT), fibrinogen, antithrombin III, platelet aggregation) are done on admission and after 6 hours - with a smooth course of the perioperative period. If it is necessary or the development of disorders in the form of bleeding or thrombosis that require correction, ROTEM and a coagulogram are done, treatment is carried out, and after elimination of the causes, ROTEM and a coagulogram are examined in dynamics to assess the effectiveness of the therapy.
- Conditions
- Aortic Surgery, Coagulation Management
- Being tested
- ROTEM and standard coagulation tests
- Keywords
- ROTEM, coagulation tests, coagulation disorders, aortic surgery
- Medical subject headings
- Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROTEM and standard coagulation testsDevice
ROTEM and standard coagulation tests assessment
What is being measured
The primary outcome is the main question the study is designed to answer.
The coagulation index
Сhanges of the coagulation index
Measured: an average of during the first day after surgery
Activated coagulation time
Сhanges of the activated coagulation time
Measured: an average of during the first day after surgery
Secondary outcomes (3)
Percentage of repeated operations
Percentage of repeated operations
Measured: an average of 24 hours after surgery
Percentage of multiple organ failure
Percentage of multiple organ failure
Measured: an average of 24 hours after surgery
Percentage of serious infectious complication
Percentage of serious infectious complication
Measured: an average of 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2021
- Study start1 Nov 2021
- Primary completion1 Nov 2022
- Study completion25 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic SurgeryStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Petrovsky National Research Centre of Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleksandr Eremenko, Petrovsky National Research Centre of Surgery
- Investigators
- Aleksandr Eremenko, MD, Study director, Petrovsky National Research Centre of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05171023
- Sponsor's protocol ID
- 20210916-11
- Status last verified
- Aug 2023
- First submitted
- 16 Nov 2021
- Last updated
- 30 Aug 2023
- 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 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of ROTEM Technology in Aortic Surgery Under Cardiopulmonary Bypass and Circulatory Arrest
- ClinicalTrials.gov ID
- NCT05171023
- Acronym / sponsor ID
- 20210916-11
- Conditions
- Aortic Surgery, Coagulation Management
- Keywords
- ROTEM, coagulation tests, coagulation disorders, aortic surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Petrovsky National Research Centre of SurgeryUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 25 Aug 2023 (actual)
- First posted
- 28 Dec 2021 (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.
Comparison of the diagnostic capabilities of rotational thromboelastometry (ROTEM) and standard coagulogram in the detection of disorder and correction of the hemostasis system in the perioperative period in patients who underwent surgical intervention on the aorta under cardiopulmonary bypass and or circulatory arrest.
Detailed description
The patient is monitored in the intensive care unit according to the following scheme: ROTEM (NATEM, INTEM, EXTEM, FIBTEM; with high clotting time (CT) values in INTEM - HEPTEM is done) and a coagulogram (activated coagulation time (ACT), activated partial thromboplastin time (APTT), prothrombin time (PT), thrombin time (TT), fibrinogen, antithrombin III, platelet aggregation) are done on admission and after 6 hours - with a smooth course of the perioperative period. If it is necessary or the development of disorders in the form of bleeding or thrombosis that require correction, ROTEM and a coagulogram are done, treatment is carried out, and after elimination of the causes, ROTEM and a coagulogram are examined in dynamics to assess the effectiveness of the therapy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients after surgical interventions on the aorta with cardiopulmonary bypass and/or circulatory arrest.
Key inclusion criteria (2 listed)
- Age from 18 to 80 years.
- Patients after surgical interventions on the aorta with cardiopulmonary bypass and/or circulatory arrest (operations on the ascending aorta, aortic arch and thoracoabdominal aorta).
Key exclusion criteria (1 listed)
- Patients with other cardiac surgery, including isolated endovascular interventions on the aorta.
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 |
|---|---|---|
| ROTEM and standard coagulation testsROTEM and standard coagulation tests assessment | Device | – |
Primary outcome
The coagulation index
Time frame: an average of during the first day after surgery
Сhanges of the coagulation index
Activated coagulation time
Time frame: an average of during the first day after surgery
Сhanges of the activated coagulation time
3 secondary outcomes
Percentage of repeated operations
Time frame: an average of 24 hours after surgery
Percentage of multiple organ failure
Time frame: an average of 24 hours after surgery
Percentage of serious infectious complication
Time frame: an average of 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
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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.
Aleksandr Eremenko, MD study director
Petrovsky National Research Centre of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Surgery and Coagulation Management, run by Petrovsky National Research Centre of Surgery 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 30 Aug 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The coagulation index (time frame: an average of during the first day after surgery). The study lists 2 primary outcomes in all. 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 30 Aug 2023.