Clinical Trials Directory

Trials / Completed

CompletedNCT05171023

Application of ROTEM Technology in Aortic Surgery

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

Status
Completed
Phase
Study type
Observational
Enrollment
81 (actual)
Sponsor
Petrovsky National Research Centre of Surgery · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEROTEM and standard coagulation testsROTEM and standard coagulation tests assessment

Timeline

Start date
2021-11-01
Primary completion
2022-11-01
Completion
2023-08-25
First posted
2021-12-28
Last updated
2023-08-30

Locations

1 site across 1 country: Russia

Source: ClinicalTrials.gov record NCT05171023. Inclusion in this directory is not an endorsement.