NCT Number: NCT03699813
ROTEM Versus aPTT/PT in Pediatric Surgery
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.
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Notify MeKey information
Conditions
Age range
5 year–18 year
Sex eligibility
All sexes
Study type
Observational
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- pediatric patients after surgical correction of scoliosis
Exclusion criteria
- patients older than 18 years
Treatment and study plan
Primary outcomes
-
analysing blood loss during surgery
Time frame: 3 years
blood loss during scoliosis surgery will analysed in both groups
Secondary outcomes
-
analysing blood transfusion units consumption
Time frame: 3 years
consumption of blood transfusion products will be analysed in both groups
-
time to results of tests
Time frame: 3 years
time to available results of test ROTEM and aPTT/PT will be analysed and compared between both groups
Sponsors and collaborators
Lead sponsor
University Hospital, Motol
Other
Registry information
Official study title
Use of Rotational Thromboelastometry (ROTEM) in Pediatric Perioperative Medicine and Its Comparison With Standard Coagulation Tests aPTT/PT
Important dates
- Study start
- 2015
- Primary completion
- 2018
- Study completion
- 2018
- First posted
- Oct 9, 2018
- Registry last updated
- Oct 11, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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