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ROTEM Versus aPTT/PT in Pediatric Surgery

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ClinicalTrials.gov Identifier: NCT03699813
Recruitment Status : Completed
First Posted : October 9, 2018
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Durila Miroslav MUDr. Ph.D., University Hospital, Motol

Study Description
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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
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
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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 : February 2, 2015
Actual Primary Completion Date : September 15, 2018
Actual Study Completion Date : September 15, 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. analysing blood loss during surgery [ Time Frame: 3 years ]
    blood loss during scoliosis surgery will analysed in both groups


Secondary Outcome Measures :
  1. analysing blood transfusion units consumption [ Time Frame: 3 years ]
    consumption of blood transfusion products will be analysed in both groups

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
pediatric patients who underwent surgical scoliosis correction
Criteria

Inclusion Criteria:

• pediatric patients after surgical correction of scoliosis

Exclusion Criteria:

• patients older than 18 years

Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Durila Miroslav MUDr. Ph.D., associated professor, University Hospital, Motol
ClinicalTrials.gov Identifier: NCT03699813    
Other Study ID Numbers: 05102018
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: All data of study will be available in published paper

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Durila Miroslav MUDr. Ph.D., University Hospital, Motol:
ROTEM, PT, aPTT
Additional relevant MeSH terms:
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Hemostatic Disorders
Blood Coagulation Disorders
Hematologic Diseases
 Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders