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

NCT ID: NCT04617808

Last Updated: 2022-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

715 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-21

Study Completion Date

2021-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Headache Emergencies

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Headache pattern

Telephone call from center 15 for the headache pattern

Questionnaire

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Régional d'Orléans

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

JULIEN PASSERIEUX, Dr

Role: STUDY_CHAIR

CHR ORLEANS

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Regional Hospital center of Orleans

Orléans, , France

Site Status

CHRU de Tours

Tours, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 25600719 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16686907 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18785014 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29133539 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24065011 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25754613 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 5687926 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CHRO-2019-02

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Botox Injection in Treatment of Chronic Migraine
NCT02259075 COMPLETED PHASE1/PHASE2