Spinal FusionNCT01742936

Point of Care Testing in Pediatric Patients Undergoing Major Surgery

A study testing CoaguChek and Hospital Laboratory in people with Spinal Fusion and Cardiopulmonary Bypass, run by Nationwide Children's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 2 to 18 years
Conditions the study is for: Spinal Fusion, Cardiopulmonary Bypass
What is being tested?: CoaguChek and Hospital Laboratory
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteUnited States
Study dates: Feb 2013to Jan 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Undergoing elective posterior spinal fusion surgery at Nationwide Children's Hospital
Parents willing \& able to provide informed consent
Child able to provide assent (if age appropriate)

Who cannot join

Pre-existing bleeding disorders
Any other circumstance which, in the opinion of the investigator, would put the patient at increased risk.

Trial locations and contacts

1 site in 1 country.

United States1 site

Nationwide Children's Hospital
Columbus, Ohio, 43205

Other trials in United States

About this study

Official title: Point of Care Testing for Coagulation Function Versus Standard Laboratory Testing in Pediatric Patients Undergoing Major Surgery

The current study proposes to investigate Point of Care Testing (POCT) (Coagcheck®) and compare obtained results versus standard laboratory coagulation parameters prothrombin time (PT) and partial thromboplastin time (PTT). The time difference in obtaining the two results will also be examined. A total of 100 pediatric patients undergoing spinal surgery or cardiopulmonary bypass will be enrolled and consented per protocol. Blood samples will be obtained simultaneously tested on both the standard laboratory apparatus and the Coagcheck® device. If the two results are comparable, this could have immediate clinical application and impact in the operating room as POCT results are available within 2-3 minutes compared to 1-2 hours for standard laboratory samples.

Conditions: Spinal Fusion, Cardiopulmonary Bypass
Being tested: CoaguChek, Hospital Laboratory

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CoaguChekDevice
Hand held coagulation monitor.
Hospital LaboratoryOther
Coagulation testing done by hospital laboratory.

Study groups in NCT01742936
Study group	Role	What they receive
Spinal fusion	Experimental	Patients undergoing a posterior spinal fusion and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory. Receives: Device: CoaguChek; Other: Hospital Laboratory
Cardiac bypass	Experimental	Patients undergoing surgery requiring cardiopulmonary bypass and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory. Receives: Device: CoaguChek; Other: Hospital Laboratory

What is being measured

The primary outcome is the main question the study is designed to answer.

International Normalized Ratio (INR) on CoaguChek
Measuring the blood's ability to clot on a handheld monitor.
Measured: At end of surgery (an average of 2-4 hrs for cardiac bypass and 4-6 hrs. for spinal fusion)
International Normalized Ratio (INR) Performed by Hospital Laboratory
Measuring the bloods ability to clot by the hospital's reference laboratory.
Measured: At end of surgery (an average of 2-4 hrs for cardiac bypass and 4-6 hrs. for spinal fusion)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2013Jan 2015

First posted6 Dec 2012 (estimated)
Study startFeb 2013
Primary completionJan 2015
Study completionJan 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Spinal FusionStudies of the same condition, open and under way.
More trials run by Nationwide Children's HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01742936
Sponsor's protocol ID: IRB12-00762
Status last verified: Jul 2016
First submitted: 3 Dec 2012
Last updated: 25 Aug 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis
RecruitingObservational study
Lumbar & Sacroiliac Fusion Study Involving Previously Implanted Devices
Fusion of Spine, Sacroiliac; Fusion
Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion

All Spinal Fusion trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Point of Care Testing for Coagulation Function Versus Standard Laboratory Testing in Pediatric Patients Undergoing Major Surgery
ClinicalTrials.gov ID: NCT01742936
Acronym / sponsor ID: IRB12-00762
Conditions: Spinal Fusion, Cardiopulmonary Bypass
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Nationwide Children's HospitalUniversity, hospital or other
Study start: Feb 2013
Primary completion: Jan 2015 (actual)
Study completion: Jan 2015 (actual)
First posted: 6 Dec 2012 (estimated)
Results: Posted 8 Jun 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Spinal fusion	Experimental	Device: CoaguChek, Other: Hospital LaboratoryPatients undergoing a posterior spinal fusion and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.
Cardiac bypass	Experimental	Device: CoaguChek, Other: Hospital LaboratoryPatients undergoing surgery requiring cardiopulmonary bypass and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.

Who may qualify

Ages: 2 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

Undergoing elective posterior spinal fusion surgery at Nationwide Children's Hospital
Parents willing \& able to provide informed consent
Child able to provide assent (if age appropriate)

Key exclusion criteria (2 listed)

Pre-existing bleeding disorders
Any other circumstance which, in the opinion of the investigator, would put the patient at increased risk.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CoaguChekHand held coagulation monitor.	Device	Cardiac bypass, Spinal fusion
Hospital LaboratoryCoagulation testing done by hospital laboratory.	Other	Cardiac bypass, Spinal fusion

Primary outcome

International Normalized Ratio (INR) on CoaguChek
Time frame: At end of surgery (an average of 2-4 hrs for cardiac bypass and 4-6 hrs. for spinal fusion)
Measuring the blood's ability to clot on a handheld monitor.
International Normalized Ratio (INR) Performed by Hospital Laboratory
Time frame: At end of surgery (an average of 2-4 hrs for cardiac bypass and 4-6 hrs. for spinal fusion)
Measuring the bloods ability to clot by the hospital's reference laboratory.

Results and safety

Results posted to the registry on 8 Jun 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Spinal Fusion	50	50
Cardiac Bypass	50	50

Primary outcome: International Normalized Ratio (INR) on CoaguChek

Time frame: At end of surgery (an average of 2-4 hrs for cardiac bypass and 4-6 hrs. for spinal fusion). Mean (Standard Deviation). Unit: ratio

Measure	Spinal Fusion n = 49	Cardiac Bypass n = 38
Value	1.11 (0.07)	4.6 (2.1)

Primary outcome: International Normalized Ratio (INR) Performed by Hospital Laboratory

Time frame: At end of surgery (an average of 2-4 hrs for cardiac bypass and 4-6 hrs. for spinal fusion). Mean (Standard Deviation). Unit: ratio

Measure	Spinal Fusion n = 49	Cardiac Bypass n = 38
Value	1.2 (0.1)	3.5 (3.2)

Population analysed: Three cases of device error with CoaguChek®, 1 insufficient blood for measurement in the laboratory, and 1 communication failure during sending the blood sample to the laboratory occurred leaving 87 patients for analysis.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Spinal Fusion	0 of 50 (0%)	0 of 50 (0%)	Not reported
Cardiac Bypass	0 of 50 (0%)	0 of 50 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Spinal Fusion

RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis
RecruitingObservational study
Lumbar & Sacroiliac Fusion Study Involving Previously Implanted Devices
Fusion of Spine, Sacroiliac; Fusion
Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CoaguChek and Hospital Laboratory in people with Spinal Fusion and Cardiopulmonary Bypass, run by Nationwide Children's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

International Normalized Ratio (INR) on CoaguChek (time frame: At end of surgery (an average of 2-4 hrs for cardiac bypass and 4-6 hrs. for spinal fusion)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01742936.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2016.