ROTEM Versus aPTT/PT in Pediatric Surgery

Sponsor

University Hospital, Motol (Other)

Overall Status

Completed

CT.gov ID

NCT03699813

Collaborator

(none)

Enrollment

43.4

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coagulation Defect; Bleeding	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 Design

Study Type:

Observational

Actual Enrollment :

45 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Feb 2, 2015

Actual Primary Completion Date :

Sep 15, 2018

Actual Study Completion Date :

Sep 15, 2018

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

analysing blood loss during surgery [3 years]
blood loss during scoliosis surgery will analysed in both groups

Secondary Outcome Measures

analysing blood transfusion units consumption [3 years]
consumption of blood transfusion products will be analysed in both groups
time to results of tests [3 years]
time to available results of test ROTEM and aPTT/PT will be analysed and compared between both groups

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

• pediatric patients after surgical correction of scoliosis

Exclusion Criteria:

• patients older than 18 years

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Hospital, Motol

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Durila Miroslav MUDr. Ph.D., associated professor, University Hospital, Motol

ClinicalTrials.gov Identifier:

NCT03699813

Other Study ID Numbers:

05102018

First Posted:

Oct 9, 2018

Last Update Posted:

Oct 11, 2018

Last Verified:

Oct 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Durila Miroslav MUDr. Ph.D., associated professor, University Hospital, Motol

ROTEM, PT, aPTT

Additional relevant MeSH terms:

Hemostatic Disorders

Blood Coagulation Disorders

Study Results

No Results Posted as of Oct 11, 2018