NCT05171023

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 28, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2023

Completed
Last Updated

August 30, 2023

Status Verified

August 1, 2023

Enrollment Period

1 year

First QC Date

November 16, 2021

Last Update Submit

August 27, 2023

Conditions

Aortic SurgeryCoagulation Management

Keywords

ROTEMcoagulation testscoagulation disordersaortic surgery

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Percentage of repeated operations

    an average of 24 hours after surgery

  • Percentage of multiple organ failure

    an average of 24 hours after surgery

  • Percentage of serious infectious complication

    an average of 24 hours after surgery

Interventions

ROTEM and standard coagulation testsDEVICE

ROTEM and standard coagulation tests assessment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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).

You may not qualify if:

  • Patients with other cardiac surgery, including isolated endovascular interventions on the aorta.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Petrovsky National Research Centre of Surgery

Moscow, 119991, Russia

Location

MeSH Terms

Conditions

Hemostatic Disorders

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Aleksandr Eremenko, MD

    Petrovsky National Research Centre of Surgery

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

November 16, 2021

First Posted

December 28, 2021

Study Start

November 1, 2021

Primary Completion

November 1, 2022

Study Completion

August 25, 2023

Last Updated

August 30, 2023

Record last verified: 2023-08

Locations

RU(1)