Application of ROTEM Technology in Aortic Surgery

NCT ID: NCT05171023

Last Updated: 2023-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

81 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-01

Study Completion Date

2023-08-25

Brief Summary

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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

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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

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Aortic Surgery Coagulation Management

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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ROTEM and standard coagulation tests

ROTEM and standard coagulation tests assessment

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Petrovsky National Research Centre of Surgery

OTHER

Sponsor Role lead

Responsible Party

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Aleksandr Eremenko

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aleksandr Eremenko, MD

Role: STUDY_DIRECTOR

Petrovsky National Research Centre of Surgery

Locations

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Petrovsky National Research Centre of Surgery

Moscow, , Russia

Site Status

Countries

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Russia

Other Identifiers

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20210916-11

Identifier Type: -

Identifier Source: org_study_id

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