Child Clinical Trial - A Comparison of Laboratory Versus Point of Care

Status Completed

Clinical Trial Summary

Clinical Trial Description

The overall aim of the study is to determine whether point-of-care (bedside) Activated Partial Thromboplastin Time (APTT) testing would be better than laboratory APTT testing in the PICU population (restricted to children under 16 years of age). To do this the investigators need to compare both forms of testing in the following areas: 1. Accuracy - using laboratory results as our control the investigators want to ascertain how reliable Point-of-care (bedside) testing with the Hemochron Signature Elite is by comparing paired samples. The Hemochron Signature Elite Whole Blood Microcoagulation System is a battery-operated, hand-held instrument that performs individual point-of-care coagulation tests, including APTT, on fresh or citrated whole blood. The Hemochron Signature Elite instrument is CE marked and complies with multiple safety standard requirements and directives. The investigators know that the Hemochron Signature Elite is not 100% accurate compared to the laboratory but the degree of inaccuracy, particularly in the paediatric population is not clear, if within acceptable & predictable limits the investigators would still be able to use this in clinical practice. 2. Time efficiency - in view of the fact the Hemochron Signature Elite is on PICU, results from this will be almost immediately available. The investigators then want to measure exactly how long it takes from the moment the laboratory sample is taken for the results to be available. 3. Cost-effectiveness - the investigators want to compare the costs of these two types of testing in detail, including costs for the Hemochron Signature Elite machine, Hemochron Signature Elite cuvettes, laboratory Clotting Screen bottles, laboratory Clotting Screen analysis, and maintaining the two different types of equipment. The investigators will also take into account any other regular costs (e.g. porters to take samples to the laboratory when the pod system is down). The investigators plan on seeking assistance from senior paediatric colleagues with more experience of health economics in doing a costs minimisation analysis ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04744701
Study type	Observational
Source	University of Leeds
Contact
Status	Completed
Phase
Start date	February 10, 2020
Completion date	April 1, 2020

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06320626` - Pharmacokinetic-guided Dosing of Emicizumab	Phase 4
Completed	`NCT04011852` - The Role of Chest Electrical Impedance Tomography in the Pediatric Ventilator Weaning
Completed	`NCT03497663` - VIA Family - Family Based Early Intervention Versus Treatment as Usual	N/A
Recruiting	`NCT05016271` - Health Benefits of Air Purifiers in Primary School Students	N/A
Completed	`NCT02551978` - Kids Obesity Prevention Program - Study (KOP)	N/A
Completed	`NCT02240368` - Performance Evaluation of the Depth of Anesthesia Monitors in Pediatric Surgery
Completed	`NCT03946137` - Chest Therapy and Postural Education in Children With Cerebral Palsy	N/A
Completed	`NCT01918020` - Impact Study of Minnesota SNAP-Ed Health and Nutrition Education Programs	N/A
Completed	`NCT01267097` - The PAC Study: Parents as Agents of Change in Pediatric Weight Management	N/A
Recruiting	`NCT04022460` - Using Personal Mobile Technology to Identify Obstructive Sleep Apnea in Children With Down Syndrome (UPLOAD)
Completed	`NCT05538039` - Reducing Anxiety of Children and Their Parents in the Pre-elective Surgery Process	N/A
Completed	`NCT03156465` - Iowa Cochlear Implant Clinical Research Center Hybrid L24 and Standard Cochlear Implants in Profoundly Deaf Infants	N/A
Not yet recruiting	`NCT05914324` - Outpatient Pediatric Pulse Oximeters in Africa	N/A
Not yet recruiting	`NCT04827108` - Psychometric Properties of the Chinese Version of PeNAT
Recruiting	`NCT04888195` - Symptom Clusters in Hong Kong Chinese Children With Blood Cancer
Completed	`NCT05374902` - Efficacy of Animation, Buzzy, and Multiple Interventions on Pain in Children	N/A
Not yet recruiting	`NCT04853303` - VR to Improve CINV, Sleep and Pain Among Children With Cancer in HK	N/A
Completed	`NCT04665453` - Dexmedetomidine and Melatonin for Sleep Induction for EEG in Children	N/A
Completed	`NCT04082247` - Healthy Children 2021 Study in Childcare Centers	N/A
Completed	`NCT02858531` - Predictive Tracking of Patient Flow in the Emergency Services During the Virus Winter Epidemics

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

A Comparison of Laboratory Versus Point of Care (Bedside) APTT Testing

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms