CEPHAREG: Predictive Score for Non-traumatic Secondary Headache After an Emergency Call

Sponsor
Centre Hospitalier Régional d'Orléans (Other)
Overall Status
Completed
CT.gov ID
NCT04617808
Collaborator
(none)
715
2
7.3
357.5
49

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Questionnaire

Detailed Description

Headache accounted for 1% of outpatient consultations, 2% of hospital emergency department visits and, at the French national level, 1% of complaints motivating calls to the prehospital emergency medical service units (The French, physician-led Emergency Calls Centers , called either "Center 15" or Service d'Aide Médicale d'Urgence [SAMU]). In 2009, the French "SAMU-Urgences de France" society proposed a classification and diagnostic tool for evaluating the headache patient, which is yet to be validated by a clinical study. Most patients with headache spontaneously consulted the emergency department (ED) and only 4 to 5% of patients entered ED through ambulance, fire and rescue department, medicalized ambulance (SMUR), or police. Patients attending emergency service for unusual sudden headache arriving by ambulance had a higher frequency of subarachnoid haemorrhage.

Headache studies have mainly been conducted in the ED. The Ottawa rule published by Perry et al. in 2013 proposed criteria for conducting explorations for subarachnoid hemorrhage (SAH) in patients over 15 years of age with severe, non-traumatic headache, having reached maximum intensity within one hour.

Unlike the primary headaches, secondary headaches are associated with underlying causes. Among the severe secondary headaches (SSH) (4 to 5% of headaches), non-traumatic subarachnoid haemorrhage was not diagnosed in 5.4% to 12% of cases in ED resulting in increase in mortality from 5 to 14%.

In 2018, French guidelines for the emergency management of headache recognized criteria likely to be at risk of Severe Secondary Headache, requiring explorations in emergencies for sudden headaches or thunderclaps headaches (i.e. reaching maximum intensity in less than a minute), recent headaches or progressive worsening (<7 days) and unusual, association with fever (apart from an obvious cause), association with signs of neurological impairment, suspicion of carbon monoxide poisoning, immunosuppression (neoplasia, HIV). Any unusual headache in a patient with recurrent paroxysmal or chronic headache should be considered secondary until proven otherwise. Subarachnoid hemorrhages were present in 11% of patients with sudden, intense and unusual headache.

In the French department of Loiret, patients with subarachnoid haemorrhage required a transfer out of the department to the nearest regional referral teaching hospital, by lack of adequate equipment and expertise for interventional neurology. Early diagnosis was therefore critical. In fact, an untreated cerebral aneurysm rupture increased bleeding recurrence by 3-4% in the first 24 hours.

Study Design

Study Type:
Observational
Actual Enrollment :
715 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Predictive Score for Non-traumatic Secondary Headache After an Emergency Call
Actual Study Start Date :
Oct 21, 2020
Actual Primary Completion Date :
May 31, 2021
Actual Study Completion Date :
May 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Headache pattern

Telephone call from center 15 for the headache pattern

Other: Questionnaire
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

Outcome Measures

Primary Outcome Measures

  1. Proportion of patients with diagnosis of non-traumatic secondary headache [Day 21]

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

Secondary Outcome Measures

  1. Proportion of patients requiring an admission to Intensive Care Unit [Day 2]

    Proportion of patients requiring an admission to the Intensive Care Unit between triage in the emergency department (Day 0) and Day 2

  2. Number of patients with early mortality [Day 7]

    Number of patients who died in hospital at day 7

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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)

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Regional Hospital center of Orleans Orléans France 45067
2 CHRU de Tours Tours France 37044

Sponsors and Collaborators

  • Centre Hospitalier Régional d'Orléans

Investigators

  • Study Chair: JULIEN PASSERIEUX, Dr, CHR ORLEANS

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Centre Hospitalier Régional d'Orléans
ClinicalTrials.gov Identifier:
NCT04617808
Other Study ID Numbers:
  • CHRO-2019-02
First Posted:
Nov 5, 2020
Last Update Posted:
Mar 28, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Régional d'Orléans
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 28, 2022