NCT02926703

Brief Summary

The investigators compared the feasibility of serum creatine kinase and serum lactate concentration as diagnostic markers to distinguish between generalized tonic-clonic seizures (GTCS) and syncopes in clinical settings that require fast-action treatment, such as in the emergency departments.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 6, 2016

Completed
Last Updated

October 7, 2016

Status Verified

September 1, 2016

Enrollment Period

9 months

First QC Date

October 5, 2016

Last Update Submit

October 6, 2016

Conditions

SeizureSyncope

Keywords

seizurelactatecreatine kinase

Outcome Measures

Primary Outcomes (1)

  • Comparison of the first measurements of serum lactate and creatine kinase concentrations in blood samples between patients admitted with either a generalized tonic-clonic seizure or a syncope

    2 hours

Secondary Outcomes (1)

  • Comparison of the serum lactate concentrations at admission with the CK follow-up taken 10 to 48 hours after the event

    48 hours

Study Arms (2)

GTCS patients

Patients with generalized tonic-clonic seizures (GTCS) and whose serum lactate and creatine kinase (CK) concentrations in blood samples had been measured within 2 hours after the event. In a subgroup of patients follow up blood samples were taken at 10 to 48 hours after the seizure to allow longitudinal the comparison of both markers

Other: Serum lactate and CK concentrations in blood samples

Syncope patients

Patients with syncope and whose serum lactate and CK concentrations in blood samples had been measured within 2 hours after the event. In a subgroup of patients follow up blood samples were taken at 10 to 48 hours after the seizure to allow longitudinal the comparison of both markers.

Other: Serum lactate and CK concentrations in blood samples

Interventions

Serum lactate and CK concentrations in blood samplesOTHER

Serum lactate and CK concentrations in blood samples were measured routinely at admission

GTCS patientsSyncope patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Emergency department patients

You may qualify if:

  • Patients with generalized tonic-clonic seizures and syncopes and whose blood samples were taken within 2 hours after the event
  • years or older
  • Observed seizure
  • Time of the event before admission was known
  • Diagnosis of an epileptic seizure or syncope had been entered in the final discharge report

You may not qualify if:

  • Prisoner
  • Age \< 18 years old
  • Competing explanations for serum lactate or CK elevation e.g. shock or trauma
  • Lack of capacity for consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology/Emergency department, University Hospital RWTH Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Related Publications (1)

  • Matz O, Zdebik C, Zechbauer S, Bundgens L, Litmathe J, Willmes K, Schulz JB, Dafotakis M. Lactate as a diagnostic marker in transient loss of consciousness. Seizure. 2016 Aug;40:71-5. doi: 10.1016/j.seizure.2016.06.014. Epub 2016 Jun 23.

    PMID: 27367837BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

2-5 ml blood sample for the measurements of serum lactate and creatine kinase concentrations

MeSH Terms

Conditions

SeizuresSyncope

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsUnconsciousnessConsciousness DisordersNeurobehavioral Manifestations

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Manuel Dafotakis, Dr.

    Department of Neurology, University Hospital RWTH Aachen, Germany

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2016

First Posted

October 6, 2016

Study Start

November 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

October 7, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)