NCT04617808

Brief Summary

The study objective was to identify predictive criteria of severe non-traumatic secondary headache among the information gathered during telephone interview conducted by the on-call regulating physician at the Centre15.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
715

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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

October 21, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 5, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

March 28, 2022

Status Verified

March 1, 2022

Enrollment Period

7 months

First QC Date

October 28, 2020

Last Update Submit

March 25, 2022

Conditions

Keywords

headacheEmergency

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with diagnosis of non-traumatic secondary headache

    Proportion of patients with diagnosis of non-traumatic secondary headache attended by the French emergency services operating

    Day 21

Secondary Outcomes (2)

  • Proportion of patients requiring an admission to Intensive Care Unit

    Day 2

  • Number of patients with early mortality

    Day 7

Study Arms (1)

Headache pattern

Telephone call from center 15 for the headache pattern

Other: Questionnaire

Interventions

The regulatory scheme applied to all investigative centers is as follows: * Call from Center 15 by a major patient for secondary headache no traumatic. (i.e. not having been the victim of a head trauma during the 48 hours preceding the call) * Detection of the pattern of "non-traumatic headache", by the regulatory assistant medical with registration of the word "cephareg" in the medical regulation software in order to alert the regulator about the possible inclusion of the patient * If possible, patient information on the collection of their data for research and possibility of opposing * Filling of a medical questionnaire by the regulating doctor * Weekly collection of medical questionnaires by investigating doctors

Headache pattern

Eligibility Criteria

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

The patients presenting all the inclusion criteria and not showing any of the non-inclusion criteria will be included prospectively and consecutively when calling for medical regulation from the SAMU 45. The patients will be included in the study by the doctor regulator.

You may qualify if:

  • Telephone call from center 15 for the headache pattern
  • Age ≥ 18
  • Non-opposition expressed by the patient
  • Or non-opposition delayed (adults with cognitive disorders, protected adults, clinical situations judged to be serious by the Medical Regulation Assistant, physician regulator, incoming call flow, call by close or trusted person)

You may not qualify if:

  • Head trauma \< 48 hours
  • Moribund patient
  • Non-affiliation to a social security scheme
  • Opposition to the continuation of the study expressed orally by the patient or by return mail within 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Regional Hospital center of Orleans

Orléans, 45067, France

Location

CHRU de Tours

Tours, 37044, France

Location

Related Publications (7)

  • Burch RC, Loder S, Loder E, Smitherman TA. The prevalence and burden of migraine and severe headache in the United States: updated statistics from government health surveillance studies. Headache. 2015 Jan;55(1):21-34. doi: 10.1111/head.12482. Erratum In: Headache. 2015 Feb;55(2):356.

    PMID: 25600719BACKGROUND
  • Goldstein JN, Camargo CA Jr, Pelletier AJ, Edlow JA. Headache in United States emergency departments: demographics, work-up and frequency of pathological diagnoses. Cephalalgia. 2006 Jun;26(6):684-90. doi: 10.1111/j.1468-2982.2006.01093.x.

    PMID: 16686907BACKGROUND
  • Valade D. The Emergency Headache Center at the Lariboisiere Hospital: 7 years with more than 70,000 patients. Intern Emerg Med. 2008 Oct;3 Suppl 1:S3-7. doi: 10.1007/s11739-008-0191-6.

    PMID: 18785014BACKGROUND
  • Perry JJ, Sivilotti MLA, Sutherland J, Hohl CM, Emond M, Calder LA, Vaillancourt C, Thirganasambandamoorthy V, Lesiuk H, Wells GA, Stiell IG. Validation of the Ottawa Subarachnoid Hemorrhage Rule in patients with acute headache. CMAJ. 2017 Nov 13;189(45):E1379-E1385. doi: 10.1503/cmaj.170072.

    PMID: 29133539BACKGROUND
  • Perry JJ, Stiell IG, Sivilotti ML, Bullard MJ, Hohl CM, Sutherland J, Emond M, Worster A, Lee JS, Mackey D, Pauls M, Lesiuk H, Symington C, Wells GA. Clinical decision rules to rule out subarachnoid hemorrhage for acute headache. JAMA. 2013 Sep 25;310(12):1248-55. doi: 10.1001/jama.2013.278018.

    PMID: 24065011BACKGROUND
  • Pari E, Rinaldi F, Gipponi S, Venturelli E, Liberini P, Rao R, Padovani A. Management of headache disorders in the Emergency Department setting. Neurol Sci. 2015 Jul;36(7):1153-60. doi: 10.1007/s10072-015-2148-7. Epub 2015 Mar 10.

    PMID: 25754613BACKGROUND
  • Chey WY, Kusakcioglu O, Dinoso V, Lorber SH. Gastric secretion in patients with chronic pancreatitis and in chronic alcoholics. Arch Intern Med. 1968 Nov;122(5):399-403. No abstract available.

    PMID: 5687926BACKGROUND

MeSH Terms

Conditions

HeadacheEmergencies

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • JULIEN PASSERIEUX, Dr

    CHR ORLEANS

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

October 28, 2020

First Posted

November 5, 2020

Study Start

October 21, 2020

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

March 28, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations