- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02772653
Evaluation of Resuscitation Markers in Trauma Patients
Severe trauma patients have an elevated risk of multiple organ failure and death. In order to increase survival possibilities the initial treatment must be focused into resuscitation from shock. Traditionally the most common resuscitation markers used are vital signs and urine output. Unfortunately, many patients might present normal vital signs, but still undergo a compensated shock with persistent acidosis, hence being able to develop multiple organ failure and death. Consequently, it is important to define better resuscitation markers for these patients.
This investigation project consists in an observational prospective study, performed by a multidisciplinary team, in which different resuscitation markers are evaluated in severe trauma patients. There will be a specific timing (1st, 8th and 24th hours from arrival) evaluation of different markers: hemodynamic (vital signs, urine output, etc); analytical (lactate, base excess, natriuretic atrial peptide); tissue perfusion markers (NIRS); microcirculation markers (videomicroscopy) and coagulopathy markers (thromboelastometry). There will be a registry of total volume administration; blood cell transfusions and vasoactive drug requirements. Each marker will be evaluated in relation to mortality; multiple organ failure; massive transfusion protocol activation; blood cell transfusion requirement; surgical control of bleeding requirement and emergent arteriographic embolization. The objective of this study is to demonstrate which of these markers is better to predict hemodynamic evolution of severe trauma patients and might become a guide for resuscitation in the future.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
Barcelona
-
Sabadell, Barcelona, Spagna, 08208
- Corporacion Sanitaria Parc Tauli
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Pre-hospital Priority 0 protocol activation:
- Glasgow coma scale < 14
- Systolic blood pressure < 90 mmHg
- Respiratory rate < 10 or > 29 breaths per minute
- Absent peripheral pulses
- Pre-hospital Priority 1 protocol activation:
- All penetratin injuries to head, neck, torso and extremities proximal to elbow and knee
- Flail chest
- Two or more proximal long-bone fractures
- Crushed, degloved or mangled extremity
- Amputation proximal to wrist and ankle
- Pelvic fracture
- Open or depressed skull fracture
- Paralysis
Exclusion Criteria:
- Hospitalization < 24 hours ( transport of the patient to an other trauma center)
- Patients transported from an other hospital (first hours of medical support done elsewhere)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
---|---|
Severe trauma patients
No interventions are done. It's a prospective and descriptive observational study where different markers are analyzed:
All these markers are analyzed at the 1rst, 8th and 24th hour from hospital admission. |
Analyzed at the 1rst, 8th and 24th hour from hospital admission
Analyzed at the 1rst, 8th and 24th hour from hospital admission
Analyzed at the 1rst, 8th and 24th hour from hospital admission
Analyzed at the 1rst, 8th and 24th hour from hospital admission
Analyzed at the 1rst, 8th and 24th hour from hospital admission
Analyzed at the 1rst, 8th and 24th hour from hospital admission
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Mortality
Lasso di tempo: Through study completion, an average of 1-2 years
|
Death of the patient
|
Through study completion, an average of 1-2 years
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Multiple organ dysfunction (Multiple Organ Dysfunction Score)
Lasso di tempo: Through study completion, an average of 1-2 years
|
Marshall's score (MODS Score) consist on the analysis of 6 systems through different descriptors, those descriptors include: a) the respiratory system (pO2/FIO2 ratio); b) the renal system (serum creatinine concentration); c) the hepatic system (serum bilirrubine concentration); d) the hematologic system (platelet count); and e) the central nervous system (Glasgow Coma Scale); and f) the cardiovascular system (pressure adjusted heart rate).
The cardiovascular system descriptor is calculated as the product of the heart rate and the ratio of central venous pressure to mean arterial pressure.
All these descriptors will be measured during the first 24h from hospital admission.
|
Through study completion, an average of 1-2 years
|
Blood cell transfusion
Lasso di tempo: Through study completion, an average of 1-2 years
|
Need for blood cell transfusion for patients
|
Through study completion, an average of 1-2 years
|
Activation of the Massive blood transfusion protocol
Lasso di tempo: At hospital admission
|
Need for massive transfusion protocol activation on patients with suspicion of active bleeding
|
At hospital admission
|
Surgical intervention for bleeding control
Lasso di tempo: Through study completion, an average of 1-2 years
|
Need for surgical control on patients with active bleeding
|
Through study completion, an average of 1-2 years
|
Arteriographic embolization for bleeding control
Lasso di tempo: Through study completion, an average of 1-2 years
|
Need for arteriographic embolization on patients with active bleeding
|
Through study completion, an average of 1-2 years
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Hospital stay
Lasso di tempo: Through study completion, an average of 1-2 years
|
Number of days that the patient remains in hospital
|
Through study completion, an average of 1-2 years
|
Intensive care unit stay
Lasso di tempo: Through study completion, an average of 1-2 years
|
Number of days that the patient remains in the intensive care unit
|
Through study completion, an average of 1-2 years
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Andrea Campos-Serra, MD, Corporacion Sanitaria Parc Tauli
- Direttore dello studio: Salvador Navarro-Soto, MD, PhD, Corporacion Sanitaria Parc Tauli
- Direttore dello studio: Sandra Montmany-Vioque, MD, PhD, Corporacion Sanitaria Parc Tauli
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CSPT-CG-PPT1
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Blood Lactate
-
Haydarpasa Numune Training and Research HospitalCompletatoDisturbo della coagulazioneTacchino
-
Cerus CorporationReclutamento
-
University Hospital, RouenNon ancora reclutamentoEpatite B | Epatite C | AIDSFrancia
-
MicroPhage, Inc.CompletatoSepsi | Batteriemia | Infezione | Infezione da stafilococcoStati Uniti
-
University Hospital TuebingenReclutamentoPredisposizione genetica alla malattia | Malattie RareGermania
-
University of UtahAlbert Einstein College of Medicine; University of California, San Francisco; National... e altri collaboratoriCompletato
-
Cerus CorporationTerminatoMalattia acuta da virus EbolaStati Uniti
-
University of the Balearic IslandsCompletatoPressione sanguigna | Allenamento di resistenzaSpagna
-
Tokat Gaziosmanpasa UniversityCompletatoDenti decidui | Pulpotomia | Sanguinamento pulpare; ColorazioneTacchino
-
Universidade Federal do CearaNon ancora reclutamento