- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03019900
Survey of Blood Transfusion Practices in Critically Ill Patients at High Altitude
Encuesta Sobre prácticas de transfusión de glóbulos Rojos en el Paciente crítico Atendido en Unidades de Altura
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Anemia has been identified as a common complication in the critically ill patient. Approximately 40 and 60% are transfused in normal clinical practice. However transfusions are not free of adverse events including: transfusion-associated lung injury, infectious complications, progression of organ failure, fluid overload associated with transfusion, among others. Therefore, several clinical trials have been designed to define red blood cell transfusion thresholds. Mainly two groups have been compared: 1) liberal schemes in which patients are transfused with higher levels of hemoglobin (generally ≤ 10 g / dL) and restrictive regimens with lower levels (≤ 7 g / dL). Institutions such as the British Committee for Standards in Hematology have developed recommendations in favor of restrictive strategies based mainly on the TRICC (Transfusion Requirements In Critical Care) study conducted by Hebert et al.
On the other hand, it is well known that as consequences of living in places at high altitude physiological modifications occur in the human. One of these adaptations is the increase in hemoglobin levels occurring in people living at high altitude, especially in Andean residents, in whom the hypoxia promotes an increase in the production of red blood cells.
The recommendation of the restrictive strategy in the transfusion of red blood cells has been adopted in several countries with numerous populations living at high altitudes, although this practice has not been evaluated in these patients.
The purpose of this study is to describe the current practice on transfusion of red blood cells in critical patients treated in intensive care units located in high altitude areas (over 1500 m) to determine whether physicians follow the recommendations of restrictive strategies.
This is an observational, non-randomized, cross-sectional survey performed with intensivists of Bolivia, Colombia, Ecuador, México and Perú. The data will be collected from an on-line scenaries based survey. The survey is designated to assessed the effect of severity, need of surgery, severe hypoxia, and alteration in tisular perfusion as modifiers of transfusion thresholds. Besides unit characteristics as geographical altitude and type of unit will be collected.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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Pichincha
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Quito, Pichincha, Ecuador
- Nadia Montero
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
Intensivists who work in intensive care units localized above 1500 meters above sea level
Exclusion Criteria:
- fellows, retired members and pediatrics intensivists
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Cross sectional survey.
Tidsramme: 1 day
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the red blood cell transfusion threshold is going to be assessed in specific sceneries raised in the survey
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1 day
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Nadia Montero, physician, Universidad Tecnológica Equinoccial
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- EPTGRA
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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