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

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.

Study Overview

• Status: Completed
• Conditions: Coagulation Defect; Bleeding
• Intervention / Treatment: Other: Comparison of two approaches to bleeding management

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.

• Study Type: Observational
• Enrollment (Actual): 45

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

pediatric patients who underwent surgical scoliosis correction

Description

Inclusion Criteria:

• pediatric patients after surgical correction of scoliosis

Exclusion Criteria:

• patients older than 18 years

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
scoliosis bleeding management based on aPTT/PT; 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
scoliosis bleeding management based on ROTEM; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Motol

Publications and helpful links

General Publications

• Jonas J, Durila M, Malosek M, Maresova D, Stulik J, Barna M, Vymazal T. Usefulness of perioperative rotational thrombelastometry during scoliosis surgery in children. J Neurosurg Spine. 2020 Jan 24:1-6. doi: 10.3171/2019.11.SPINE191137. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 2, 2015
• Primary Completion (ACTUAL): September 15, 2018
• Study Completion (ACTUAL): September 15, 2018

Study Registration Dates

• First Submitted: October 5, 2018
• First Submitted That Met QC Criteria: October 5, 2018
• First Posted (ACTUAL): October 9, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 11, 2018
• Last Update Submitted That Met QC Criteria: October 9, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: ROTEM, PT, aPTT
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Blood Coagulation Disorders
• Other Study ID Numbers: 05102018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: All data of study will be available in published paper

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No