ROTEM Versus aPTT/PT in Pediatric Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Coagulation Defect; Bleeding

Intervention / Treatment
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* Other: Comparison of two approaches to bleeding management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • pediatric patients after surgical correction of scoliosis Exclusion Criteria: • patients older than 18 years

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| scoliosis bleeding management based on aPTT/PT<br>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. | Other: Comparison of two approaches to bleeding management<br> <br> |
| scoliosis bleeding management based on ROTEM<br>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. | Other: Comparison of two approaches to bleeding management<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analysing blood loss during surgery | blood loss during scoliosis surgery will analysed in both groups | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analysing blood transfusion units consumption | consumption of blood transfusion products will be analysed in both groups | 3 years | 
| time to results of tests | time to available results of test ROTEM and aPTT/PT will be analysed and compared between both groups | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ROTEM, PT, aPTT