ROTEM Versus aPTT/PT in Pediatric Surgery

Coagulation Defect; Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03699813
• Other study ID #: 05102018
• Status: Completed
• Start date: February 2, 2015
• Est. completion date: September 15, 2018

Study information

• Verified date: October 2018
• Source: University Hospital, Motol
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 15, 2018
• Est. primary completion date: September 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

Inclusion Criteria:

• pediatric patients after surgical correction of scoliosis

Exclusion Criteria:

• patients older than 18 years

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Coagulation Defect; Bleeding
• Hemostatic Disorders

Intervention

Other:
• Comparison of two approaches to bleeding management

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Motol

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	analysing blood loss during surgery	blood loss during scoliosis surgery will analysed in both groups	3 years
Secondary	analysing blood transfusion units consumption	consumption of blood transfusion products will be analysed in both groups	3 years
Secondary	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