PRBC TransfusionNCT02585310
Packed Red Blood Cell Transfusion in Elective Coronary Artery Bypass Graft Surgery in A University Hospital
An observational study of PRBC Transfusion and CABGs, run by Mahidol University.
Trial summary
In Siriraj Hospital, blood consumption in Cardiac surgery is high (units per patient) and frequent (number of patients receiving blood). The incidence of side effects are unknown, as is the exact amount of blood used/provided for patients with elective CABGs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PRBC Transfusion, CABGs
- What is being tested?
- Packed red blood cell transfusion
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Nov 2011to Sep 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing CABGs
Who may be able to join
- patients undergoing first-time isolated elective coronary artery bypass graft surgery
Who cannot join
- None
About this study
In Siriraj Hospital, blood consumption in Cardiac surgery is high (units per patient) and frequent (number of patients receiving blood). The incidence of side effects are unknown, as is the exact amount of blood used/provided for patients with elective CABGs.
The primary objective of this study was to demonstrate the incidence of packed red blood cell (PRBC) transfusion in elective CABGs.
Read the detailed description
Three hundred patients undergoing isolated, first time CABGs during November 2011-September 2013 were prospective enrolled in this observational study. Patients' preoperative variables and postoperative outcomes, as well as perioperative transfusion characteristics were recorded.
- Conditions
- PRBC Transfusion, CABGs
- Being tested
- Packed red blood cell transfusion
- Keywords
- PRBC transfusion, CABGs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Packed red blood cell transfusionOther
Record number of PRBC transfusion during perioperative period.
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of PRBC transfusion in elective CABG surgery
Measured: 14 days
Secondary outcomes (1)
risk factors of PRBC transfusion in elective CABG surgery
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2015 (estimated)
- Study startNov 2011
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PRBC TransfusionStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sirilak Suksompong, Mahidol University
- Investigators
- Sirilak Suksompong, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02585310
- Sponsor's protocol ID
- SI1
- Status last verified
- Oct 2015
- First submitted
- 21 Oct 2015
- Last updated
- 23 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Packed Red Blood Cell Transfusion in Elective Coronary Artery Bypass Graft Surgery in A University Hospital
- ClinicalTrials.gov ID
- NCT02585310
- Acronym / sponsor ID
- SI1
- Conditions
- PRBC Transfusion, CABGs
- Keywords
- PRBC transfusion, CABGs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 23 Oct 2015 (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.
In Siriraj Hospital, blood consumption in Cardiac surgery is high (units per patient) and frequent (number of patients receiving blood). The incidence of side effects are unknown, as is the exact amount of blood used/provided for patients with elective CABGs.
The primary objective of this study was to demonstrate the incidence of packed red blood cell (PRBC) transfusion in elective CABGs.
Detailed description
Three hundred patients undergoing isolated, first time CABGs during November 2011-September 2013 were prospective enrolled in this observational study. Patients' preoperative variables and postoperative outcomes, as well as perioperative transfusion characteristics were recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing CABGs
Key inclusion criteria (1 listed)
- patients undergoing first-time isolated elective coronary artery bypass graft surgery
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Packed red blood cell transfusionRecord number of PRBC transfusion during perioperative period. | Other | – |
Primary outcome
incidence of PRBC transfusion in elective CABG surgery
Time frame: 14 days
1 secondary outcome
risk factors of PRBC transfusion in elective CABG surgery
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2015.
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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.
Sirilak Suksompong, MD principal investigator
Mahidol University
Questions about this trial
What is this clinical trial studying?
An observational study of PRBC Transfusion and CABGs, run by Mahidol University.
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: finished, as of the sponsor's last update on 23 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of PRBC transfusion in elective CABG surgery (time frame: 14 days). 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 23 Oct 2015.