- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Nadia Montero, physician
- Phone Number: 593 995189435
- Email: nadiamonteromd@gmail.com
Study Locations
-
-
Pichincha
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Quito, Pichincha, Ecuador
- Nadia Montero
-
Contact:
- Solange Nuñez, physician
- Phone Number: 593 958982015
- Email: solnun@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Intensivists who work in intensive care units localized above 1500 meters above sea level
Exclusion Criteria:
- fellows, retired members and pediatrics intensivists
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cross sectional survey.
Time Frame: 1 day
|
the red blood cell transfusion threshold is going to be assessed in specific sceneries raised in the survey
|
1 day
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Nadia Montero, physician, Universidad Tecnológica Equinoccial
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EPTGRA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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