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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03699813
Enrollment
45
Registered
2018-10-09
Start date
2015-02-02
Completion date
2018-09-15
Last updated
2018-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coagulation Defect; Bleeding

Keywords

ROTEM, PT, aPTT

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.

Interventions

OTHERComparison of two approaches to bleeding management

Sponsors

University Hospital, Motol
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

• pediatric patients after surgical correction of scoliosis

Exclusion criteria

• patients older than 18 years

Design outcomes

Primary

MeasureTime frameDescription
analysing blood loss during surgery3 yearsblood loss during scoliosis surgery will analysed in both groups

Secondary

MeasureTime frameDescription
analysing blood transfusion units consumption3 yearsconsumption of blood transfusion products will be analysed in both groups
time to results of tests3 yearstime to available results of test ROTEM and aPTT/PT will be analysed and compared between both groups

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026