Application of ROTEM Technology in Aortic Surgery

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.

Study Overview

• Status: Completed
• Conditions: Aortic Surgery; Coagulation Management
• Intervention / Treatment: Device: ROTEM and standard coagulation tests

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 Type: Observational
• Enrollment (Actual): 81

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 119991
    • Petrovsky National Research Centre of Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients after surgical interventions on the aorta with cardiopulmonary bypass and/or circulatory arrest.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The coagulation index	Сhanges of the coagulation index	an average of during the first day after surgery
Activated coagulation time	Сhanges of the activated coagulation time	an average of during the first day after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of repeated operations	Percentage of repeated operations	an average of 24 hours after surgery
Percentage of multiple organ failure	Percentage of multiple organ failure	an average of 24 hours after surgery
Percentage of serious infectious complication	Percentage of serious infectious complication	an average of 24 hours after surgery

Collaborators and Investigators

• Sponsor: Petrovsky National Research Centre of Surgery
• Investigators: Study Director: Aleksandr Eremenko, MD, Petrovsky National Research Centre of Surgery

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): August 25, 2023

Study Registration Dates

• First Submitted: November 16, 2021
• First Submitted That Met QC Criteria: December 27, 2021
• First Posted (Actual): December 28, 2021

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 27, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: ROTEM; aortic surgery; coagulation disorders; coagulation tests
• Other Study ID Numbers: 20210916-11

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No