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Application of ROTEM Technology in Aortic Surgery

Application of ROTEM Technology in Aortic Surgery Under Cardiopulmonary Bypass and Circulatory Arrest

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05171023
Enrollment
81
Registered
2021-12-28
Start date
2021-11-01
Completion date
2023-08-25
Last updated
2023-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Surgery, Coagulation Management

Keywords

ROTEM, coagulation tests, coagulation disorders, aortic surgery

Brief 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 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.

Interventions

DEVICEROTEM and standard coagulation tests

ROTEM and standard coagulation tests assessment

Sponsors

Petrovsky National Research Centre of Surgery
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 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).

Exclusion criteria

* Patients with other cardiac surgery, including isolated endovascular interventions on the aorta.

Design outcomes

Primary

MeasureTime frameDescription
The coagulation indexan average of during the first day after surgeryСhanges of the coagulation index
Activated coagulation timean average of during the first day after surgeryСhanges of the activated coagulation time

Secondary

MeasureTime frameDescription
Percentage of repeated operationsan average of 24 hours after surgeryPercentage of repeated operations
Percentage of multiple organ failurean average of 24 hours after surgeryPercentage of multiple organ failure
Percentage of serious infectious complicationan average of 24 hours after surgeryPercentage of serious infectious complication

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026