Application of ROTEM Technology in Aortic Surgery

Completed

• Conditions: Coagulation Management; Aortic Surgery

• Registration Number: NCT05171023
• Lead Sponsor: Petrovsky National Research Centre of 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.

Study Timeline

• Study Start: 2021-11-01
• Study First Submitted: 2021-11-16
• Study First Submitted QC: 2021-12-27
• Study First Posted: 2021-12-28
• Primary Completion: 2022-11-01
• Status Verified: 2023-08
• Study Completion: 2023-08-25
• Last Update Submitted: 2023-08-27
• Last Update Posted: 2023-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Activated coagulation time	an average of during the first day after surgery	Сhanges of the activated coagulation time
The coagulation index	an average of during the first day after surgery	Сhanges of the coagulation index

Secondary Outcome Measures

Name	Time	Method
Percentage of serious infectious complication	an average of 24 hours after surgery	Percentage of serious infectious complication
Percentage of repeated operations	an average of 24 hours after surgery	Percentage of repeated operations
Percentage of multiple organ failure	an average of 24 hours after surgery	Percentage of multiple organ failure

Trial Locations

Locations (1)

Petrovsky National Research Centre of Surgery; 🇷🇺 Moscow, Russian Federation