ROTEM Versus aPTT/PT in Pediatric Surgery

NCT03699813 | Completed

• 1 other identifier: 05102018
• Study Type: observational
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coagulation Defect; Bleeding

Keywords

ROTEM, PT, aPTT

Outcome Measures

Primary Outcomes (1)

• analysing blood loss during surgery

  blood loss during scoliosis surgery will analysed in both groups

  3 years

Secondary Outcomes (2)

• analysing blood transfusion units consumption

  3 years

• time to results of tests

  3 years

Study Arms (2)

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

Interventions

Comparison of two approaches to bleeding management OTHER

scoliosis bleeding management based on ROTEM; scoliosis bleeding management based on aPTT/PT

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

pediatric patients who underwent surgical scoliosis correction

You may qualify if:

• pediatric patients after surgical correction of scoliosis

You may not qualify if:

• patients older than 18 years

Sponsors & Collaborators

• University Hospital, Motol: lead

Related Publications (1)

• 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;32(6):865-870. doi: 10.3171/2019.11.SPINE191137. Print 2020 Jun 1.

  PMID: 31978886 DERIVED

MeSH Terms

Conditions

Hemostatic Disorders; Hemorrhage

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associated professor

Study Record Dates

• First Submitted: October 5, 2018
• First Posted: October 9, 2018
• Study Start: February 2, 2015
• Primary Completion: September 15, 2018
• Study Completion: September 15, 2018
• Last Updated: October 11, 2018

Record last verified: 2018-10