Prehospital mSOFA-Kit Decision Support for the Detection of Multiple Organ Failure (mSOFA-Kit)
Design, Construction and Clinical Validation of the mSOFA-Kit: Integrated Device for the Detection of Prehospital Multiple Organ Failure. A Cluster-Randomized Clinical Trial
The goal of this clinical trial is to learn whether the mSOFA-Kit, a decision support system that calculates the modified Sequential Organ Failure Assessment (mSOFA) score on scene, improves the outcomes of adults attended by Advanced Life Support Units (USVA) for a potentially critical condition.
The main question it aims to answer is: does systematic on-scene stratification of multiorgan risk with the mSOFA-Kit reduce the 2-day composite adverse outcome (all-cause mortality, in-hospital cardiac arrest, admission to a level 2 or 3 ICU, invasive mechanical ventilation or renal replacement therapy) compared with the standard XABCDE assessment?
Researchers will compare USVAs using the mSOFA-Kit with a visible score (intervention arm) with USVAs applying standard XABCDE care with a blinded mSOFA score (control arm). Ambulance units, not individual patients, are randomly assigned to each arm. In both arms, a small venous blood sample, obtained from the peripheral venous catheter already placed for clinical care, is analyzed on scene with a point-of-care analyzer.
Participants will:
- receive the usual prehospital care of their emergency service;
- have their on-scene data and their hospital outcomes recorded;
- be followed up to 90 days through medical records and death registries.
Visão geral do estudo
Status
Status
Condições
Condições
Intervenção / Tratamento
Intervenção / Tratamento
Descrição detalhada
Background. Prehospital multiple organ failure (MOF) is associated with high early mortality. The mSOFA score assesses five organ systems (respiratory SpO2/FiO2, Glasgow Coma Scale, creatinine, mean arterial pressure and lactate; total 0-17 points). In the predecessor project DTS23/00010, the mSOFA predicted 2-day mortality with an AUC of 0.949 (95% CI 0.939-0.958) in 12,212 patients (Alonso et al., eClinicalMedicine 2025).
Device. The mSOFA-Kit is an integrated system whose core is the mSOFA-App, Software as a Medical Device (Class IIb, Rule 11 MDR) without its own CE marking (Category (a), Royal Decree 192/2023 and Article 62 MDR). In the clinical investigation, the mSOFA-App operates with the epoc NXS point-of-care analyzer (Siemens Healthineers) and with the vital signs monitor of each USVA, both CE-marked and already part of the units' equipment.
Design. Multicenter, controlled, parallel-group (1:1) cluster-randomized clinical trial (cluster = USVA), with outcome assessment blinded to arm (PROBE design). Randomization is computerized, stratified by annual care volume of the USVA and type of unit (ground mobile ICU vs. air ambulance helicopter), in random permuted blocks. Outcomes are adjudicated by a Clinical Events Committee blinded to arm. An independent Data Safety Monitoring Board oversees safety.
Setting. Phase 1 takes place in Castilla y Leon, in the network of the Gerencia de Emergencias Sanitarias de Castilla y Leon (22 Mobile Emergency Units and 10 air ambulance helicopters). Outcome data are collected observationally at the 14 receiving hospitals of the SACYL network. Expansion to other Spanish regions (Phase 2) is planned if recruitment criteria are met.
Informed consent. Three pathways according to the patient's capacity: prior consent of the competent patient (IC-A), consent of the legal representative (IC-B) or deferred consent after stabilization (IC-C), with double verification of capacity by two crew members. Clinical care always takes precedence over any study procedure.
Sample size. 3,600 patients in Phase 1 (3,780 to be recruited, allowing for 5% losses); 5,220 (5,481 to be recruited) if Phase 2 is activated. Alpha 0.05 (two-sided), power 80%, expected reduction of the composite outcome from 25% to 20%.
Analysis. Generalized linear mixed model (binomial, logit link) with a random effect for cluster, adjusted for prespecified covariates; intention-to-treat as the primary analysis. One interim analysis at 50% of Phase 1 recruitment (Haybittle-Peto efficacy boundary, conditional power futility rule).
Statistical Analysis Plan. The Statistical Analysis Plan (version 1.0), including 23 prespecified exploratory outcomes and the economic evaluation, was signed on October 27, 2026, before inclusion of the first participant, and is publicly available: doi:10.5281/zenodo.23696842.
Tipo de estudo
Tipo de estudo
Inscrição (Estimado)
Inscrição
Estágio
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
Contato de estudo
- Nome: Francisco Martín-Rodríguez, PhD
- Número de telefone: +34 983 423 721
- E-mail: francisco.martin.rodriguez@uva.es
Locais de estudo
-
-
Castille and León
-
Valladolid, Castille and León, Espanha
- Gerencia de Emergencias Sanitarias de Castilla y León
-
Contato:
- Francisco Martín-Rodríguez, PhD
- Número de telefone: +34 983 423 721
- E-mail: francisco.martin.rodriguez@uva.es
-
-
Critérios de participação
Critérios de elegibilidade
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Age 18 years or older at the time of the incident.
- Attended by an Advanced Life Support Unit (USVA) participating in the study during the recruitment period.
- Clinical condition with any of the following characteristics that triggers systematic assessment: suspected sepsis, stroke, acute coronary syndrome, severe trauma (estimated ISS > 15), shock (any etiology), neurological deterioration (GCS < 13), severe acute dyspnea, or significant hemodynamic alteration (HR > 130 or < 45 bpm, or SBP < 90 mmHg).
- Possibility of obtaining at least one venous point-of-care blood determination (0.1 mL).
- Valid informed consent obtained according to the pathway defined in the protocol (prior consent from the competent patient, consent from the legal representative, or deferred consent from the patient after stabilization, as appropriate).
Exclusion Criteria:
- Patient in refractory cardiorespiratory arrest with a documented decision to limit life-sustaining treatment before the arrival of the USVA.
- Express refusal to participate by the patient or, where applicable, by their legally designated representative.
- Patient deprived of liberty or in a situation of special vulnerability that compromises the validity of the informed consent.
- Simultaneous participation in another clinical or device trial whose interaction compromises the mSOFA assessment (to be assessed by the site coordinator).
- Patient previously included in the study during the same care episode (only the first response is included).
- Pregnancy (known or evident).
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Número de braços
Armas e Intervenções
Grupo de Participantes / BraçoGrupo de Participantes / Braço |
Intervenção / TratamentoIntervenção / Tratamento |
|---|---|
|
Experimental: mSOFA-Kit (visible score)
The USVA has the fully operational mSOFA-Kit. The mSOFA score, the risk category and the protocol-based recommendations are visible to the team and are used in clinical decision-making (triage, activation of codes, hospital pre-alert, final destination). |
Decision support system whose core is the mSOFA-App (Software as a Medical Device, Class IIb). From a venous point-of-care blood test (epoc NXS analyzer) and the vital signs of the USVA monitor, it automatically calculates the mSOFA score (0-17), stratifies the patient into 5 risk levels and displays protocol-based recommendations; it also supports structured pre-alert to the receiving hospital. |
|
Comparador Ativo: Standard XABCDE care (blinded mSOFA score)
The USVA applies the standard XABCDE protocol of its emergency service. The same point-of-care blood test is performed and the care team has access to its results, which it interprets according to usual practice. The mSOFA score is neither calculated nor displayed on scene. |
Standard prehospital care protocol (eXsanguination, Airway, Breathing, Circulation, Disability, Exposure) of each emergency medical service, with the point-of-care blood test available to the professional but without calculation or display of the mSOFA score. |
O que o estudo está medindo?
Medidas de resultados primários
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Composite adverse outcome at 2 days
Prazo: 48 hours (+/- 6 hours) after hospital admission
|
Occurrence of at least one of the following clinically adjudicated events during the first 48 hours after arrival at the receiving hospital: (a) all-cause mortality; (b) in-hospital cardiac arrest; (c) admission to a level 2 or 3 ICU; (d) need for invasive mechanical ventilation; (e) need for renal replacement therapy. Adjudicated by the Clinical Events Committee blinded to arm. |
48 hours (+/- 6 hours) after hospital admission
|
Medidas de resultados secundários
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
28-day mortality
Prazo: 28 days (+/- 2 days)
|
All-cause mortality within 28 days after prehospital care. |
28 days (+/- 2 days)
|
|
90-day mortality
Prazo: 90 days (+/- 5 days)
|
All-cause mortality within 90 days after care |
90 days (+/- 5 days)
|
|
ICU-free days at 28 days
Prazo: Day 28
|
Number of days between day 0 and day 28 on which the patient is alive and not admitted to the ICU (0 if the patient dies during the period or remains in the ICU for the full 28 days). |
Day 28
|
|
Mechanical ventilation-free days at 28 days
Prazo: Day 28
|
Number of days between day 0 and day 28 on which the patient is alive and not receiving mechanical ventilation (invasive, or non-invasive sustained for more than 12 consecutive hours). |
Day 28
|
|
Vasoactive drug-free days at 28 days
Prazo: Day 28
|
Number of days between day 0 and day 28 on which the patient is alive and not receiving norepinephrine, dopamine, epinephrine or vasopressin by continuous intravenous infusion. |
Day 28
|
|
Total hospital length of stay
Prazo: From prehospital care (day 0) until hospital discharge or in-hospital death, whichever came first, assessed up to 28 days
|
Number of days from prehospital care to hospital discharge or in-hospital death; days at all hospitals are added in case of transfer. |
From prehospital care (day 0) until hospital discharge or in-hospital death, whichever came first, assessed up to 28 days
|
|
Appropriate activation of time-dependent codes
Prazo: From USVA arrival at the patient (day 0) up to 1 hour after hospital arrival
|
Proportion of patients with the appropriate clinical code (sepsis, stroke, acute myocardial infarction, major trauma) activated within the time recommended by emergency medical service guidelines and scientific societies. |
From USVA arrival at the patient (day 0) up to 1 hour after hospital arrival
|
|
Time to definitive intervention
Prazo: Up to 24 hours after USVA arrival
|
Time (minutes) from arrival of the USVA at the patient to the first definitive intervention at the receiving hospital (start of targeted antibiotic therapy, thrombolysis, percutaneous coronary intervention, surgical damage control). |
Up to 24 hours after USVA arrival
|
|
Rate of serious adverse events attributable to the device
Prazo: From inclusion (day 0) up to 90 days for each participant
|
Serious adverse events clinically attributable to the use of the mSOFA-Kit (categorized by the Clinical Events Committee) over the total number of patients in the intervention arm. Prespecified acceptance threshold: < 0.5%. |
From inclusion (day 0) up to 90 days for each participant
|
|
Rate of device deficiencies
Prazo: From first participant inclusion through study completion, up to 31 months
|
Device deficiencies (point-of-care testing failure, loss of connectivity, software error, discrepancy with the manufacturer's specifications) over the total number of uses. Threshold: < 3%. |
From first participant inclusion through study completion, up to 31 months
|
|
Serious incidents reported to EUDAMED
Prazo: From first participant inclusion through study completion, up to 31 months
|
Number of serious incidents reported to the Spanish Agency of Medicines and Medical Devices (AEMPS) via EUDAMED in accordance with MDCG 2020-10/1. |
From first participant inclusion through study completion, up to 31 months
|
|
Under-triage attributable to the score
Prazo: Day 2
|
Proportion of patients in the intervention arm with an mSOFA score < 3 but with an adverse outcome at 2 days. |
Day 2
|
|
Over-triage attributable to the score
Prazo: Day 2
|
Proportion of patients in the intervention arm with an mSOFA score >= 4 but without an adverse outcome at 2 days and without need for ICU resources. |
Day 2
|
Outras medidas de resultado
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Effective use of the mSOFA-Kit
Prazo: Assessed monthly from month 1 to month 18 of recruitment (up to month 30 if Phase 2 is activated)
|
Proportion of eligible responses in the intervention arm in which the kit was used in full (score calculated + complete POCT + data transmitted to the eCRF). Target >= 85%. |
Assessed monthly from month 1 to month 18 of recruitment (up to month 30 if Phase 2 is activated)
|
|
Interobserver variability of the mSOFA score
Prazo: Day 0 (on-scene mSOFA assessment)
|
Cohen's kappa between two independent assessors on the mSOFA score calculated manually from the medical record. Target kappa > 0.90. |
Day 0 (on-scene mSOFA assessment)
|
|
Protocol adherence by USVA
Prazo: Assessed quarterly from month 1 to month 18 of recruitment (up to month 30 if Phase 2 is activated)
|
Proportion of eligible responses in the intervention arm in which the complete workflow (IC + assessment + recording) was performed as established. Target >= 85%. |
Assessed quarterly from month 1 to month 18 of recruitment (up to month 30 if Phase 2 is activated)
|
|
Technology acceptance (TAM questionnaire)
Prazo: Months 3 and 12 of use
|
Mean score (scale 1-7) on the Technology Acceptance Model questionnaire administered to USVA staff of the intervention arm. Target >= 5.0. |
Months 3 and 12 of use
|
|
Rate of deferred consent (IC-C)
Prazo: Assessed monthly from month 1 to month 18 of recruitment (up to month 30 if Phase 2 is activated)
|
Proportion of patients included through deferred consent over the total number recruited. |
Assessed monthly from month 1 to month 18 of recruitment (up to month 30 if Phase 2 is activated)
|
|
Rate of data withdrawal after deferred consent
Prazo: Assessed monthly from month 1 to month 18 of recruitment (up to month 30 if Phase 2 is activated)
|
Proportion of patients included via IC-C who, after regaining capacity, request the withdrawal of their data. |
Assessed monthly from month 1 to month 18 of recruitment (up to month 30 if Phase 2 is activated)
|
|
Change in mSOFA score (Delta mSOFA)
Prazo: 48 hours from the scene mSOFA
|
Death or increase of >= 2 points in the mSOFA within 48 h from the scene mSOFA, same scale, worst values within 48 h (lowest MAP including the value before vasoactive drugs) (SAP Appendix B). Population: ITT. Prespecified exploratory outcome EX1 (SAP v1.0, doi:10.5281/zenodo.23696842). |
48 hours from the scene mSOFA
|
|
Occult Hypoperfusion Index (OHI)
Prazo: Measured on scene; outcomes at 48 hours
|
OHI = lactate x (16 - GCS), scene values; applied only if scene mSOFA < 5; positive if >= 3.38; formula, restriction and threshold exactly as published, without refitting (del Pozo Vegas et al., BMC Medicine, accepted 2026). Calculated in the database in both arms; not displayed in the application. Population: ITT, scene mSOFA < 5. Prespecified exploratory outcome EX2 (SAP v1.0, doi:10.5281/zenodo.23696842). |
Measured on scene; outcomes at 48 hours
|
|
mSOFA decision tree
Prazo: Measured on scene; 2-day mortality
|
Classification of each patient as predicted survivor or non-survivor with the published decision tree (López Ballesteros et al., QJM, accepted 2026), applied without refitting: lactate < 4 mmol/L -> GCS >= 9.5: survivor; GCS < 9.5 -> creatinine < 1 mg/dL: survivor, >= 1: non-survivor. Lactate >= 4 mmol/L -> SpO2/FiO2 < 445: non-survivor; >= 445 -> GCS < 11.5: non-survivor; GCS >= 11.5 -> creatinine < 1.44 mg/dL: survivor, >= 1.44: non-survivor. Population: ITT. Prespecified exploratory outcome EX3 (SAP v1.0, doi:10.5281/zenodo.23696842). |
Measured on scene; 2-day mortality
|
|
Time to activation of the appropriate code (hypothesis H3)
Prazo: From USVA arrival up to 1 hour after hospital arrival
|
Minutes from USVA arrival at the patient to the first activation of the code corresponding to the hospital main diagnosis (sepsis, stroke, AMI, major trauma), on scene or in the emergency department. Population: ITT, patients with a hospital main diagnosis in these categories. Prespecified exploratory outcome EX4 (SAP v1.0, doi:10.5281/zenodo.23696842). |
From USVA arrival up to 1 hour after hospital arrival
|
|
On-scene and total prehospital time
Prazo: Day 0, from emergency activation to hospital arrival
|
On-scene time (contact to transport start) and total prehospital time (activation to hospital arrival), in minutes. Population: ITT, transported patients. Prespecified exploratory outcome EX5 (SAP v1.0, doi:10.5281/zenodo.23696842). |
Day 0, from emergency activation to hospital arrival
|
|
Effect by baseline risk
Prazo: 48 hours (+/- 6 hours) after hospital admission
|
Arm effect on the primary outcome within each scene mSOFA risk level (1-5). Population: ITT. Prespecified exploratory outcome EX6 (SAP v1.0, doi:10.5281/zenodo.23696842). |
48 hours (+/- 6 hours) after hospital admission
|
|
Safety of on-scene discharge
Prazo: 48 hours and 28 days after day 0
|
Death and primary-outcome events within 48 h and death within 28 days among patients discharged on scene without transport, by arm. Population: ITT, patients discharged on scene without transport. Prespecified exploratory outcome EX7 (SAP v1.0, doi:10.5281/zenodo.23696842). |
48 hours and 28 days after day 0
|
|
Added value over clinical judgement
Prazo: Measured on scene; outcome at 48 hours
|
Discrimination of the prior clinical judgement (patient considered critical) versus the mSOFA, and their combination, for the primary outcome; proportion of cases in which the mSOFA changed the decision (intervention arm). Population: ITT. Prespecified exploratory outcome EX8 (SAP v1.0, doi:10.5281/zenodo.23696842). |
Measured on scene; outcome at 48 hours
|
|
Destination and pre-alert
Prazo: From prehospital care to day 28
|
In patients with scene mSOFA >= 5: transport to a hospital with ICU, hospital pre-alert, and secondary inter-hospital transfer, by arm. Population: ITT, scene mSOFA >= 5. Prespecified exploratory outcome EX9 (SAP v1.0, doi:10.5281/zenodo.23696842). |
From prehospital care to day 28
|
|
Hospital SOFA
Prazo: 48 hours after hospital arrival
|
Worst SOFA score within 48 h of hospital arrival (Vincent et al., 1996), calculated from the worst values recorded (SAP Appendix B). Population: ITT, hospitalized patients. Prespecified exploratory outcome EX10 (SAP v1.0, doi:10.5281/zenodo.23696842). |
48 hours after hospital arrival
|
|
28-day readmission
Prazo: 28 days
|
Hospital readmission within 28 days of discharge. Population: ITT, patients discharged alive. Prespecified exploratory outcome EX11 (SAP v1.0, doi:10.5281/zenodo.23696842). |
28 days
|
|
Learning curve
Prazo: 48 hours (+/- 6 hours) after hospital admission, assessed by quarter from month 1 to month 18 of recruitment (up to month 30 if Phase 2 is activated)
|
Arm effect on the primary outcome according to calendar period of recruitment (quarters) and cumulative number of patients previously included by the cluster. Population: ITT. Prespecified exploratory outcome EX12 (SAP v1.0, doi:10.5281/zenodo.23696842). |
48 hours (+/- 6 hours) after hospital admission, assessed by quarter from month 1 to month 18 of recruitment (up to month 30 if Phase 2 is activated)
|
|
Suspected infection subgroup
Prazo: 48 hours (+/- 6 hours) after hospital admission
|
Arm effect on the primary outcome in patients with and without prehospital suspected infection. Population: ITT. Prespecified exploratory outcome EX13 (SAP v1.0, doi:10.5281/zenodo.23696842). |
48 hours (+/- 6 hours) after hospital admission
|
|
Validation of mSOFA risk categories
Prazo: 2 days after day 0
|
Observed 2-day mortality in each mSOFA risk level compared with the published values (0.1%, 2.5%, 16.1%, 45.3%, 76.4%; del Pozo Vegas et al., Eur J Intern Med 2026) and negative predictive value of mSOFA <= 2. Population: control arm, in which the score was not displayed; overall population as sensitivity analysis. Prespecified exploratory outcome EX14 (SAP v1.0, doi:10.5281/zenodo.23696842). |
2 days after day 0
|
|
mSOFA and longer-term mortality
Prazo: 28 and 90 days after day 0
|
Discrimination and calibration of the scene mSOFA for 28-day and 90-day mortality. Population: ITT. Prespecified exploratory outcome EX15 (SAP v1.0, doi:10.5281/zenodo.23696842). |
28 and 90 days after day 0
|
|
POCT-hospital laboratory agreement
Prazo: Day 0 (on-scene sample and first hospital laboratory sample after arrival)
|
Agreement between the scene epoc values and the first hospital laboratory values of lactate, creatinine, potassium, sodium, glucose and hemoglobin. Population: patients with both values. Prespecified exploratory outcome EX16 (SAP v1.0, doi:10.5281/zenodo.23696842). |
Day 0 (on-scene sample and first hospital laboratory sample after arrival)
|
|
Prehospital suspected infection
Prazo: From prehospital care to hospital discharge (up to day 28)
|
Sensitivity, specificity and predictive values of the prehospital item "suspected infection" for hospital sepsis (Sepsis-3); clinical profile of sepsis not suspected prehospital. Population: hospitalized patients. Prespecified exploratory outcome EX17 (SAP v1.0, doi:10.5281/zenodo.23696842). |
From prehospital care to hospital discharge (up to day 28)
|
|
Diagnostic concordance
Prazo: From prehospital care to hospital discharge (up to day 28)
|
Agreement between the prehospital main diagnosis and the hospital main diagnosis (aggregated categories of Protocol section 6.6), by arm. Population: hospitalized patients. Prespecified exploratory outcome EX18 (SAP v1.0, doi:10.5281/zenodo.23696842). |
From prehospital care to hospital discharge (up to day 28)
|
|
Analgesia
Prazo: Day 0, from USVA arrival at the patient to hospital arrival
|
Proportion of patients with pain >= 4 (VAS 0-10) receiving prehospital analgesia (morphine, fentanyl, meperidine, metamizole, paracetamol, dexketoprofen or ketamine; SAP Appendix B), by arm. Population: ITT, VAS >= 4. Prespecified exploratory outcome EX19 (SAP v1.0, doi:10.5281/zenodo.23696842). |
Day 0, from USVA arrival at the patient to hospital arrival
|
|
Mediation
Prazo: 48 hours (+/- 6 hours) after hospital admission
|
Proportion of the arm effect on the primary outcome mediated by appropriate code activation, hospital pre-alert and transport to a hospital with ICU. Population: ITT. Prespecified exploratory outcome EX20 (SAP v1.0, doi:10.5281/zenodo.23696842). |
48 hours (+/- 6 hours) after hospital admission
|
|
Physiological phenotypes
Prazo: 48 hours (+/- 6 hours) after hospital admission
|
Phenotypes identified by robust model-based clustering (TCLUST) of the scene variables, and arm effect within each phenotype. Population: ITT. Prespecified exploratory outcome EX21 (SAP v1.0, doi:10.5281/zenodo.23696842). |
48 hours (+/- 6 hours) after hospital admission
|
|
Comorbidity
Prazo: 48 hours (+/- 6 hours) after hospital admission
|
Arm effect on the primary outcome by age-adjusted Charlson Comorbidity Index (< 5 vs. >= 5). Population: ITT. Prespecified exploratory outcome EX22 (SAP v1.0, doi:10.5281/zenodo.23696842). |
48 hours (+/- 6 hours) after hospital admission
|
|
Emergency department triage
Prazo: Day 0, at emergency department arrival
|
Manchester triage level on hospital arrival, by arm and by scene mSOFA risk level. Population: transported patients. Prespecified exploratory outcome EX23 (SAP v1.0, doi:10.5281/zenodo.23696842). |
Day 0, at emergency department arrival
|
|
Cost-effectiveness
Prazo: Trial data up to 90 days; lifetime horizon by decision-analytic model
|
Incremental cost-effectiveness ratio in euros per quality-adjusted life year (QALY) gained and per composite adverse outcome avoided at 2 days, National Health System perspective, willingness-to-pay threshold EUR 25,000/QALY; QALYs estimated from survival with Spanish EQ-5D-5L population norms; lifetime horizon with 3% discount. Prespecified economic evaluation (SAP v1.0, doi:10.5281/zenodo.23696842). |
Trial data up to 90 days; lifetime horizon by decision-analytic model
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Investigadores
Investigadores
- Investigador principal: Francisco Martín-Rodríguez, PhD, University of Valladolid
Publicações e links úteis
Publicações Gerais
- Alonso E, Lopez-Izquierdo R, Bourke-Matas E, Eichinger M, Del Pozo Vegas C, de Groot B, de la Torre I, Polonio-Lopez B, Martin-Conty JL, Sanz-Garcia A, Martin-Rodriguez F. Performance of a modified Sequential Organ Failure Assessment score in pre-hospital critical care to predict short-term mortality: a prospective, multicentre, validation cohort study. EClinicalMedicine. 2025 Dec 5;90:103674. doi: 10.1016/j.eclinm.2025.103674. eCollection 2025 Dec.
- Melero-Guijarro L, Sanz-Garcia A, Martin-Rodriguez F, Lipari V, Mazas Perez Oleaga C, Carvajal Altamiranda S, Martinez Lopez NM, Dominguez Azpiroz I, Castro Villamor MA, Sanchez Soberon I, Lopez-Izquierdo R. Prehospital qSOFA, mSOFA, and NEWS2 performance for sepsis prediction: A prospective, multi-center, cohort study. Front Med (Lausanne). 2023 Apr 18;10:1149736. doi: 10.3389/fmed.2023.1149736. eCollection 2023.
- Castro Portillo E, Lopez-Izquierdo R, Castro Villamor MA, Sanz-Garcia A, Martin-Conty JL, Polonio-Lopez B, Sanchez-Soberon I, Del Pozo Vegas C, Durantez-Fernandez C, Conty-Serrano R, Martin-Rodriguez F. Modified Sequential Organ Failure Assessment Score vs. Early Warning Scores in Prehospital Care to Predict Major Adverse Cardiac Events in Acute Cardiovascular Disease. J Cardiovasc Dev Dis. 2023 Feb 17;10(2):88. doi: 10.3390/jcdd10020088.
- Martin-Rodriguez F, Sanz-Garcia A, Justel AB, Sanchez AM, Oleaga CMP, Delgado Noya I, Soberon IS, Del Pozo Vegas C, Benito JFD, Lopez-Izquierdo R. Prehospital mSOFA Score for Quick Prediction of Life-Saving Interventions and Mortality in Trauma Patients: A Prospective, Multicenter, Ambulance-based, Cohort Study. West J Emerg Med. 2023 Sep;24(5):868-877. doi: 10.5811/westjem.59048.
- Martin-Rodriguez F, Sanz-Garcia A, Del Pozo Vegas C, Ortega GJ, Castro Villamor MA, Lopez-Izquierdo R. Time for a prehospital-modified sequential organ failure assessment score: An ambulance-Based cohort study. Am J Emerg Med. 2021 Nov;49:331-337. doi: 10.1016/j.ajem.2021.06.042. Epub 2021 Jun 24.
- Castro Villamor MA, Alonso-Sanz M, Lopez-Izquierdo R, Delgado Benito JF, Del Pozo Vegas C, Lopez Torres S, Soriano JB, Martin-Conty JL, Sanz-Garcia A, Martin-Rodriguez F. Comparison of eight prehospital early warning scores in life-threatening acute respiratory distress: a prospective, observational, multicentre, ambulance-based, external validation study. Lancet Digit Health. 2024 Mar;6(3):e166-e175. doi: 10.1016/S2589-7500(23)00243-1.
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Início do estudo
Conclusão Primária (Estimado)
Conclusão Primária
Conclusão do estudo (Estimado)
Conclusão do estudo
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Primeira postagem
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última Atualização Postada
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
Outros números de identificação do estudo
- MSOFA-KIT-2026-01
- DTS26/00050 (Número de outro subsídio/financiamento: Instituto de Salud Carlos III (ISCIII))
- PS-26-13-O (Outro identificador: CEIm de las Áreas de Salud de Valladolid)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
De-identified individual participant data underlying the published results, together with the analysis scripts, will be deposited in Zenodo (with DOI) under restricted access, in accordance with the ISCIII open science policy. Access is granted only to researchers designated by the principal investigator for research related to prehospital assessment of organ failure and risk stratification, with prior authorization of the CEIm de las Areas de Salud de Valladolid, as stated in the approved participant information sheet. Data shared outside the European Economic Area will be anonymized. The Statistical Analysis Plan (version 1.0) is publicly available: doi:10.5281/zenodo.23696842.
Prazo de Compartilhamento de IPD
From publication of the primary results until the end of the data retention period (10 years after study completion).
Critérios de acesso de compartilhamento IPD
Researchers designated by the principal investigator, for projects related to the study's line of research with high scientific quality, after prior authorization of the CEIm de las Areas de Salud de Valladolid and signature of a data use agreement.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- ANALYTIC_CODE
Dados/documentos do estudo
-
Plano de Análise Estatística
Identificador de informação: 10.5281/zenodo.23696842Comentários informativos:
Statistical Analysis Plan version 1.0, signed on October 27, 2026 before inclusion of the first participant, with its supplementary eCRF data dictionary (mSOFA-App 1.0.0).
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .