Transfusion-dependent AnemiaNCT04303910
An Analysis of Blood Management in Patients Having Hip or Knee Arthroplasty
An observational study of Transfusion-dependent Anemia, run by Siriraj Hospital at 1 site in Thailand.
Trial summary
The main objective of this study is to examine the transfusion rate and appropriateness in patients undergoing elective knee and hip replacement surgery at Siriraj Hospital Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Transfusion-dependent Anemia
- How many people
- 275 participants
- Where
- 1 siteThailand
- Study dates
- 1 May 2020to 20 Sep 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients Having elective Hip or Knee Arthroplasty in Siriraj Hospital
Who may be able to join
- Patients Having elective Hip or Knee Arthroplasty in Siriraj Hospital
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Analysis of Blood Management in Patients Having Hip or Knee Arthroplasty in Siriraj Hospital: a Retrospective Study
The main objective of this study is to examine the transfusion rate and appropriateness in patients undergoing elective knee and hip replacement surgery at Siriraj Hospital
Read the detailed description
The main objective of this study is to examine the transfusion rate and appropriateness in patients undergoing elective knee and hip replacement surgery at Siriraj Hospita by reviewing data from previous medical records (retrospective chart review).
- Conditions
- Transfusion-dependent Anemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative transfusion rate
Transfusion rate in Patients Having Hip or Knee Arthroplasty in Siriraj Hospital
Measured: 1 week
Secondary outcomes (1)
Inappropriate transfusion rate
Perioperative inappropriate transfusion rate in Patients Having Hip or Knee Arthroplasty in Siriraj hospital
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start1 May 2020
- Primary completion30 Dec 2020
- Study completion20 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transfusion-dependent 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
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mingkwan Wongyingsinn, MD, Siriraj Hospital
- Investigators
- Mingkwan Wongyingsinn, MD, Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04303910
- Sponsor's protocol ID
- SIRB421_2
- Status last verified
- Sep 2021
- First submitted
- 9 Mar 2020
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Analysis of Blood Management in Patients Having Hip or Knee Arthroplasty in Siriraj Hospital: a Retrospective Study
- ClinicalTrials.gov ID
- NCT04303910
- Acronym / sponsor ID
- SIRB421_2
- Conditions
- Transfusion-dependent Anemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 11 Mar 2020 (actual)
- 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 main objective of this study is to examine the transfusion rate and appropriateness in patients undergoing elective knee and hip replacement surgery at Siriraj Hospital
Detailed description
The main objective of this study is to examine the transfusion rate and appropriateness in patients undergoing elective knee and hip replacement surgery at Siriraj Hospita by reviewing data from previous medical records (retrospective chart review).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients Having elective Hip or Knee Arthroplasty in Siriraj Hospital
Key inclusion criteria (1 listed)
- Patients Having elective Hip or Knee Arthroplasty in Siriraj Hospital
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.
Primary outcome
Perioperative transfusion rate
Time frame: 1 week
Transfusion rate in Patients Having Hip or Knee Arthroplasty in Siriraj Hospital
1 secondary outcome
Inappropriate transfusion rate
Time frame: 1 week
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 22 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Mingkwan Wongyingsinn, MD principal investigator
Siriraj Hospital
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 Transfusion-dependent Anemia, run by Siriraj Hospital at 1 site in Thailand.
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 22 Sep 2021. 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 Thailand. 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?
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?
Perioperative transfusion rate (time frame: 1 week). 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 22 Sep 2021.