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Management of the Patient at High Risk Hemorrhagic in Cardiac Surgery by Monitoring Viscoelastic Hemostasis. (ELASTICC)

R

Regional University Hospital Center (CHRU)

Status

Completed

Conditions

Cardiac Surgery

Study type

Observational

Funder types

Other

Identifiers

NCT06550505
29BRC21.0017 - ELASTICC

Details and patient eligibility

About

Evaluation and following of a protocol using viscoelastic test for the management of high risk patients in cardiac surgery

Full description

Haemorragy is a frequent issue in cardiac surgery due to multiple contributing factors. Excessive bleeding as well as transfusion are associated with increased morbidity and mortality.

Haemostatic blood products (Fibrinogen, fresh frozen plasma, platelets) transfusion had historically been guided by routine coagulation tests (aPTT, PT, platelets and fibrinogen). However, the delay (Up to 60 minutes) often leads to an empirical use of blood products in a context where clinical judgment is unreliable due to the multiples mechanisms contributing to haemostatic failure.

Using viscoelastic tests (VET) in this context has several advantages :

  • A quicker response (with first results from 10 minutes)
  • An overall evaluation of haemostatic from the clot formation to its dissolution.

The use of VET has mainly been evaluated in cardiac surgery, with several recent meta-analysis : The use of transfusion algorithms based on VET is associated with less transfusions of red blood cell concentrates, plasma and platelets and also with less mortality, less re-interventions due to excessive bleeding and less post operative renal failure.

These data led the international society for the study of hemostasis and thrombosis (ISTH) to recommend their use of VET in cardiac surgery. In France, the proposals of the peri operative hemostatis group of interest (GIHP) also support their use, specifying that there is no unique consensual algorithm.

Considering this, the investigator established a transfusion algorithm based on the Quantra, a viscoelastic device using sonorrheometry, to guide transfusion in high-risk of bleeding cardiac surgery patients.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria :

  • Adult patients
  • Elective or non-elective high risk of bleeding heart surgery
  • Non-opposition

Exclusion Criteria:

  • Pregnant women
  • Age < 18 years
  • Patients under guardianship
  • Opposition

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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