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Completed

NCT Number: NCT05171023

Application of ROTEM Technology in Aortic Surgery

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.

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Key information

Conditions

Aortic Surgery Cardiovascular Diseases Coagulation Management Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Petrovsky National Research Centre of Surgery

Moscow, 119991, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ROTEM and standard coagulation tests

Device

ROTEM and standard coagulation tests assessment

Primary outcomes

  1. The coagulation index

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

    Сhanges of the coagulation index

  2. Activated coagulation time

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

    Сhanges of the activated coagulation time

Secondary outcomes

  1. Percentage of repeated operations

    Time frame: an average of 24 hours after surgery

    Percentage of repeated operations

  2. Percentage of multiple organ failure

    Time frame: an average of 24 hours after surgery

    Percentage of multiple organ failure

  3. Percentage of serious infectious complication

    Time frame: an average of 24 hours after surgery

    Percentage of serious infectious complication

Sponsors and collaborators

Lead sponsor

Petrovsky National Research Centre of Surgery

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Dec 28, 2021
Registry last updated
Aug 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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