Use of Rotational Thromboelastometry (ROTEM) in Pediatric Perioperative Medicine and Its Comparison With Standard Coagulation Tests aPTT/PT

ROTEM Versus aPTT/PT in Pediatric Surgery

Sponsors

Lead sponsor: University Hospital, Motol

Source University Hospital, Motol
Brief Summary

Hemocoagulation management in perioperative bleeding is nowadays based on standard coagulation testing: activated partial thromboplastin time (aPTT), prothrombin time (PT), fibrinogen, D-dimers, platelets. An interest about viscoelastic coagulation testing methods is rising - use of rotational thromboelastometry (ROTEM) is mentioned in the newest European guidelines for hemostasis management. ROTEM has more advantages then standard tests. However, both tests have only grade 1C recommendation, and most of trials have been done on adults. The goal of the study is to compare a relationship between standard tests and ROTEM in pediatric patients in perioperative period to find out which test has better correlation with clinical status, to compare therapeutic strategies and time necessary for gain both of tests and to compare the difference in blood loss and blood products consumption in group treated by ROTEM versus standard tests. Reduced blood loss and amount of blood products transfusion is expected to be found in ROTEM group, representing lowering risk for the patient, all due to early evaluation of hemocoagulation and targeted therapy guided by ROTEM.

Detailed Description

Pediatric patients who underwent spine surgery (under 18 years old) will be recruited in our study.

Retrospective data will be analysed from these patient who underwent scoliosis surgery before ROTEM implementation to daily practice and after ROTEM implementation do daily practice in our department.

Time to available results of ROTEM versus aPTT/PT tests will be compared. Blood loss and blood products used in these both groups will be analysed and compared between 2 groups.

Overall Status Completed
Start Date February 2, 2015
Completion Date September 15, 2018
Primary Completion Date September 15, 2018
Study Type Observational
Primary Outcome
Measure Time Frame
analysing blood loss during surgery 3 years
Secondary Outcome
Measure Time Frame
analysing blood transfusion units consumption 3 years
time to results of tests 3 years
Enrollment 45
Condition
Intervention

Intervention type: Other

Intervention name: Comparison of two approaches to bleeding management

Eligibility

Sampling method: Non-Probability Sample

Criteria:

Inclusion Criteria:

• pediatric patients after surgical correction of scoliosis

Exclusion Criteria:

• patients older than 18 years

Gender: All

Minimum age: 5 Years

Maximum age: 18 Years

Healthy volunteers: No

Verification Date

October 2018

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: University Hospital, Motol

Investigator full name: Durila Miroslav MUDr. Ph.D.

Investigator title: associated professor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: scoliosis bleeding management based on aPTT/PT

Description: Bleeding and coagulopathy during surgery managed by clinical approach and aPTT/PT tests. Blood loss, consumption of fresh frozen plasma (FFP), red blood cell units consumption and time to aPTT/PT tests result will be analysed.

Arm group label: scoliosis bleeding management based on ROTEM

Description: Bleeding and coagulopathy during surgery managed by ROTEM. Blood loss, consumption of fresh frozen plasma (FFP), red blood cell units consumption and time to aPTT/PT tests result will be analysed.

Patient Data Undecided
Study Design Info

Observational model: Case-Control

Time perspective: Retrospective

Source: ClinicalTrials.gov