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

Completed

• Conditions: Emergencies; Headache
• Interventions: Other: Questionnaire

• Registration Number: NCT04617808
• Lead Sponsor: Centre Hospitalier Régional d'Orléans

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.

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 Timeline

• Study Start: 2020-10-21
• Study First Submitted: 2020-10-28
• Study First Submitted QC: 2020-11-04
• Study First Posted: 2020-11-05
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-25
• Last Update Posted: 2022-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 715

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Headache pattern	Questionnaire	Telephone call from center 15 for the headache pattern

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Number of patients with early mortality	Day 7	Number of patients who died in hospital at day 7

Trial Locations

Locations (2)

Regional Hospital center of Orleans; 🇫🇷 Orléans, France

CHRU de Tours; 🇫🇷 Tours, France