ROTEM Versus aPTT/PT in Pediatric Surgery
- Conditions
- Coagulation Defect; Bleeding
- Registration Number
- NCT03699813
- Lead Sponsor
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
• pediatric patients after surgical correction of scoliosis
• patients older than 18 years
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method analysing blood loss during surgery 3 years blood loss during scoliosis surgery will analysed in both groups
- Secondary Outcome Measures
Name Time Method analysing blood transfusion units consumption 3 years consumption of blood transfusion products will be analysed in both groups
time to results of tests 3 years time to available results of test ROTEM and aPTT/PT will be analysed and compared between both groups