AnemiaNCT03019900
Survey of Blood Transfusion Practices in Critically Ill Patients at High Altitude
An observational study of Anemia and Critically Ill, run by Universidad Tecnológica Equinoccial at 1 site in Ecuador.
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 Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Anemia, Critically Ill
- What is being tested?
- Red blood cells transfusions
- Type of treatment
- Surgery or procedure
- How many people
- 352 participants
- Where
- 1 siteEcuador
- Study dates
- Feb 2017to Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The records of the Latin American Intensive Medicine Research Network in high altitude (RELAMI), which has members from Bolivia, Colombia, Ecuador, Mexico and Peru, will be used as a contact source to identify active intensivists through the mailing list of members. Trying to identify intensive care units that work above 1500 meters above sea level.
Who may be able to join
- Intensivists who work in intensive care units localized above 1500 meters above sea level
Who cannot join
- fellows, retired members and pediatrics intensivists
Trial locations and contacts
1 site in 1 country.
Ecuador1 site
Nadia Montero
Quito, Pichincha
Solange Nuñez, physician, 593 958982015, solnun@hotmail.com
About this study
Official title: Encuesta Sobre prácticas de transfusión de glóbulos Rojos en el Paciente crítico Atendido en Unidades de Altura
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
Read the 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.
- Conditions
- Anemia, Critically Ill
- Being tested
- Red blood cells transfusions
- Medical subject headings
- Anemia, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red blood cells transfusionsProcedure or surgery
The survey was designated to assess the practices of blood transfusion, specifically about the threshold and factors that can modify this threshold.
What is being measured
The primary outcome is the main question the study is designed to answer.
Cross sectional survey.
the red blood cell transfusion threshold is going to be assessed in specific sceneries raised in the survey
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study startFeb 2017
- Primary completionMar 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 352 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Tecnológica Equinoccial
- Sponsor type
- University, hospital or other
- Collaborators
- Red Latinoamericana de Medicina Intensiva de Altura
- Responsible party
- Principal investigator, Nadia Montero, Universidad Tecnológica Equinoccial
- Investigators
- Nadia Montero, physician, Principal investigator, Universidad Tecnológica Equinoccial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03019900
- Sponsor's protocol ID
- EPTGRA
- Status last verified
- Jan 2017
- First submitted
- 6 Jan 2017
- Last updated
- 13 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Encuesta Sobre prácticas de transfusión de glóbulos Rojos en el Paciente crítico Atendido en Unidades de Altura
- ClinicalTrials.gov ID
- NCT03019900
- Acronym / sponsor ID
- EPTGRA
- Conditions
- Anemia, Critically Ill
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 352 participants (estimated)
- Lead sponsor
- Universidad Tecnológica EquinoccialUniversity, hospital or other
- Collaborators
- Red Latinoamericana de Medicina Intensiva de Altura
- Study start
- Feb 2017
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 13 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The records of the Latin American Intensive Medicine Research Network in high altitude (RELAMI), which has members from Bolivia, Colombia, Ecuador, Mexico and Peru, will be used as a contact source to identify active intensivists through the mailing list of members. Trying to identify intensive care units that work above 1500 meters above sea level.
Key inclusion criteria (1 listed)
- Intensivists who work in intensive care units localized above 1500 meters above sea level
Key exclusion criteria (1 listed)
- fellows, retired members and pediatrics intensivists
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Red blood cells transfusionsThe survey was designated to assess the practices of blood transfusion, specifically about the threshold and factors that can modify this threshold. | Procedure or surgery | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2017.
- Individual participant dataSharing planned: No
Related trials for Anemia
RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
Aplastic Anemia, Refractory
Active, not recruitingPhase 1
A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
Autoimmune Hemolytic Anemia, Anti-CD19 STAR T-cell Therapy
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadia Montero, physician principal investigator
Universidad Tecnológica Equinoccial
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia and Critically Ill, run by Universidad Tecnológica Equinoccial at 1 site in Ecuador.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ecuador. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nadia Montero, physician (593 995189435, nadiamonteromd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cross sectional survey. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2017.