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Clinical Trials/NCT05171023
NCT05171023
Completed
Not Applicable

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

Petrovsky National Research Centre of Surgery1 site in 1 country81 target enrollmentStarted: November 1, 2021Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Petrovsky National Research Centre of Surgery
Enrollment
81
Locations
1
Primary Endpoint
Activated coagulation time

Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts 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.

Outcomes

Primary Outcomes

Activated coagulation time

Time Frame: an average of during the first day after surgery

Сhanges of the activated coagulation time

The coagulation index

Time Frame: an average of during the first day after surgery

Сhanges of the coagulation index

Secondary Outcomes

  • Percentage of serious infectious complication(an average of 24 hours after surgery)
  • Percentage of repeated operations(an average of 24 hours after surgery)
  • Percentage of multiple organ failure(an average of 24 hours after surgery)

Investigators

Sponsor
Petrovsky National Research Centre of Surgery
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Aleksandr Eremenko

Clinical Professor

Petrovsky National Research Centre of Surgery

Study Sites (1)

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