Survey of Blood Transfusion Practices in Critically Ill Patients at High Altitude

Anemia Clinical Trial

Official title:

Encuesta Sobre prácticas de transfusión de glóbulos Rojos en el Paciente crítico Atendido en Unidades de Altura

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03019900
• Other study ID #: EPTGRA
• Status: Not yet recruiting
• Phase: N/A
• First received: January 6, 2017
• Last updated: January 12, 2017
• Start date: February 2017
• Est. completion date: April 2017

Study information

• Verified date: January 2017
• Source: Universidad Tecnológica Equinoccial
• Contact: Nadia Montero, physician
• Phone: 593 995189435
• Email: nadiamonteromd[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to describe current practice on red blood cell transfusion in critically ill patients of intensive care units located in high altitude areas

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 352
• Est. completion date: April 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

Intensivists who work in intensive care units localized above 1500 meters above sea level

Exclusion Criteria:

• fellows, retired members and pediatrics intensivists

Related Conditions & MeSH terms

• Anemia
• Critical Illness
• Critically Ill

Intervention

Procedure:
• Red blood cells transfusions
The survey was designated to assess the practices of blood transfusion, specifically about the threshold and factors that can modify this threshold.

Locations

Country	Name	City	State
Ecuador	Nadia Montero	Quito	Pichincha

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Tecnológica Equinoccial	Red Latinoamericana de Medicina Intensiva de Altura

Country where clinical trial is conducted

Ecuador, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cross sectional survey.	the red blood cell transfusion threshold is going to be assessed in specific sceneries raised in the survey	1 day