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出境医 / 临床实验 / Severity Factors and Needed Observation Time at ED of Patients Wih Head Injury (HESCTCE)
Severity Factors and Needed Observation Time at ED of Patients Wih Head Injury (HESCTCE)
Study Description
Brief Summary:
We know precisely which patients and when they should have an imaging test to evaluate a Head Injury (HI). But in those patients on anticoagulant and / or antiaggregant treatment we do not know the exact incidence of early and late hemorrhagic lesions, and there is no specific recommendation on how long they should remain under observation in the emergency department if no initial lesions are evident. Our goal is to try to answer these two questions.
| Condition or disease | Intervention/treatment |
|---|---|
| Head Injury Other Length of Stay Delayed Complications | Other: Observation |
Detailed Description:
MATERIAL: Prospective study of patients treated of HI in the Emergency Department (ED) and to whom an image test is performed (cranial CT scan). Collection of demographic, clinical, analytical, image tests, and observation time in the emergency department (from admission to medical discharge)
METHODS: Separation of subjects included in the study in 4 cohorts: patients without anticoagulant and / or antiaggregant treatment; patients with antiplatelet therapy (ASA and / or clopidogrel); patients with anticoagulant treatment with acenocoumarol and INR <2; and patients on anticoagulant therapy with acenocoumarol and INR> = 2 or patients on treatment with direct thrombin inhibitors (dabigatran), or inhibitors of factor Xa (rivaroxaban, apixaban, edoxaban) or patients on treatment with low molecular weight heparins (LMWH) ) Follow-up through analysis of clinical history and telephone interview at 2, 7, 15, 30, 60 and 90 days.
Statistical analysis of the results.
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 300 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Demographic and Clinical Data Associated to Head Injury Severity on Adults Patients (Older Than 16yo), and Follow up for 90 Days to Check the Development of Associated Complications, Deciding the Optimal Observation Lapse at ED |
| Estimated Study Start Date : | June 2019 |
| Estimated Primary Completion Date : | December 2019 |
| Estimated Study Completion Date : | March 2020 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
patients without anticoagulant and / or antiplatelet treatment
Patients older than 16yo with no anticoagulant or antiplatelet treatment attended at ED because of Head Injury and with a Head CT performed.
|
Other: Observation
Check clinical status at different time intervals during 3 months
|
|
patients on antiplatelet therapy (ASA and / or clopidogrel
Patients older than 16yo on antiplatelet treatment attended at ED because of Head Injury and with a Head CT performed.
|
Other: Observation
Check clinical status at different time intervals during 3 months
|
|
patients on treatment with acenocoumarol and INR <2
Patients older than 16yo on acenocumarol and with INR <2 attended at ED because of Head Injury and with a Head CT performed.
|
Other: Observation
Check clinical status at different time intervals during 3 months
|
|
Others
patients on anticoagulant therapy with acenocoumarol and INR> = 2 or patients on treatment with direct thrombin inhibitors (dabigatran), or inhibitors of factor Xa (rivaroxaban, apixaban, edoxaban) or patients on treatment with low molecular weight heparins (LMWH) attended at ED because of Head Injury and with a Head CT performed.
|
Other: Observation
Check clinical status at different time intervals during 3 months
|
Outcome Measures
Primary Outcome Measures :
- Severity factors associated to head injury [ Time Frame: 24 hours ]Demographical, clinical, analitical, and neuroimaging data associated to severity of HI
- Development of haemorragical complications during observation time [ Time Frame: 90 days ]Finding of an haemorragical injury associated with the head injury during follow up
Eligibility Criteria
| Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients treated by HI in the Emergency Department (ED) and to whom an imaging test is performed (cranial CT scan)
Criteria
Inclusion Criteria:
- HI attended at ED
- Head CT performed as recommended by clinical guides
- Contact data available (phone number)
Exclusion Criteria:
- Patients not able for follow up (foreigners or tourists or whatsoever whom are not going to stay on the country for at least 3 months)
Contacts and Locations
Contacts
| Contact: Enrique Torres, PhD | 0034625579066 | enrique.torres@salud.madrid.org | |
| Contact: Blanca Villacañas, PhD | blanca.villacanas@salud.madrid.org |
Locations
| Spain | |
| Hospital EL Escorial | |
| San Lorenzo de El Escorial, Madrid, Spain, 28200 | |
Sponsors and Collaborators
Hospital El Escorial
Investigators
| Study Chair: | Francisco J Favá, PhD | Hospital El Escorial |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 29, 2019 | ||||
| First Posted Date | May 31, 2019 | ||||
| Last Update Posted Date | May 31, 2019 | ||||
| Estimated Study Start Date | June 2019 | ||||
| Estimated Primary Completion Date | December 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
|
||||
| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Severity Factors and Needed Observation Time at ED of Patients Wih Head Injury | ||||
| Official Title | Demographic and Clinical Data Associated to Head Injury Severity on Adults Patients (Older Than 16yo), and Follow up for 90 Days to Check the Development of Associated Complications, Deciding the Optimal Observation Lapse at ED | ||||
| Brief Summary | We know precisely which patients and when they should have an imaging test to evaluate a Head Injury (HI). But in those patients on anticoagulant and / or antiaggregant treatment we do not know the exact incidence of early and late hemorrhagic lesions, and there is no specific recommendation on how long they should remain under observation in the emergency department if no initial lesions are evident. Our goal is to try to answer these two questions. | ||||
| Detailed Description |
MATERIAL: Prospective study of patients treated of HI in the Emergency Department (ED) and to whom an image test is performed (cranial CT scan). Collection of demographic, clinical, analytical, image tests, and observation time in the emergency department (from admission to medical discharge) METHODS: Separation of subjects included in the study in 4 cohorts: patients without anticoagulant and / or antiaggregant treatment; patients with antiplatelet therapy (ASA and / or clopidogrel); patients with anticoagulant treatment with acenocoumarol and INR <2; and patients on anticoagulant therapy with acenocoumarol and INR> = 2 or patients on treatment with direct thrombin inhibitors (dabigatran), or inhibitors of factor Xa (rivaroxaban, apixaban, edoxaban) or patients on treatment with low molecular weight heparins (LMWH) ) Follow-up through analysis of clinical history and telephone interview at 2, 7, 15, 30, 60 and 90 days. Statistical analysis of the results. |
||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients treated by HI in the Emergency Department (ED) and to whom an imaging test is performed (cranial CT scan) | ||||
| Condition |
|
||||
| Intervention | Other: Observation
Check clinical status at different time intervals during 3 months
|
||||
| Study Groups/Cohorts |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status | Unknown status | ||||
| Estimated Enrollment |
300 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | March 2020 | ||||
| Estimated Primary Completion Date | December 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
||||
| Sex/Gender |
|
||||
| Ages | 16 Years and older (Child, Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Spain | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03970421 | ||||
| Other Study ID Numbers | URGHESCHEADINJURY | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement |
|
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| Responsible Party | Hospital El Escorial | ||||
| Study Sponsor | Hospital El Escorial | ||||
| Collaborators | Not Provided | ||||
| Investigators |
|
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| PRS Account | Hospital El Escorial | ||||
| Verification Date | May 2019 | ||||
