NCT03699813

ROTEM Versus aPTT/PT in Pediatric Surgery

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 45 (actual)
• Sponsor: University Hospital, Motol · Academic / Other
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coagulation Defect; Bleeding

Interventions

Type	Name	Description
OTHER	Comparison of two approaches to bleeding management

Timeline

• Start date: 2015-02-02
• Primary completion: 2018-09-15
• Completion: 2018-09-15
• First posted: 2018-10-09
• Last updated: 2018-10-11