Total Hip or Knee ArthroplastyTRIOSNCT00726349
Transfusion Requirements in Orthopedic Surgery (PHASE 2)
An observational study of Total Hip or Knee Arthroplasty, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
The objective of our research program is to determine the transfusion threshold required to maximize functional recovery after major orthopedic surgery (total hip/knee replacement) in these, most often, elderly patient with serious comorbidities. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Total Hip or Knee Arthroplasty
- How many people
- 305 participants
- Where
- 1 siteCanada
- Study dates
- May 2008to May 2011
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing isolated elective total hip or knee arthroplasty (primary or revision surgery for a non-malignant condition), aged 60 years or older and able to walk prior to surgery.
Who may be able to join
- Patients undergoing isolated elective total hip or knee arthroplasty (primary or revision surgery for a non-malignant condition), aged 60 years or older and able to walk prior to surgery.
Who cannot join
- Since this an observational study, all patients conforming to inclusion criteria will be included.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transfusion Requirements in Orthopedic Surgery (Phase 2): A Prospective Observational Evaluation of the Optimal Transfusion Trigger.
The objective of our research program is to determine the transfusion threshold required to maximize functional recovery after major orthopedic surgery (total hip/knee replacement) in these, most often, elderly patient with serious comorbidities.
Hypothesis: we hypothesize that a threshold hemoglobin concentration exists below which functional recovery becomes difficult, even if the vital prognosis of patients is not impaired.
Read the detailed description
Anemia is frequent after a surgical procedure. Postoperative anemia is associated with an increased incidence of transfusions and, probably, with an increased incidence of morbidity and mortality. However, the majority of studies evaluating the consequences of postoperative anemia are retrospective and, since anemic patients were transfused, they are unable to distinguish between the effects of anemia per se and those of transfusion. In orthopedic surgery, only two randomized controlled trials (RCT) have attempted to determine the benefits of transfusions in this patient population. The first evaluated the benefits of allogeneic transfusions in patients undergoing surgery for a fractured hip while the second evaluated autologous transfusions in patients undergoing total knee replacement. The small number of patients included in both studies did not allow definitive conclusions on the benefits (or lack thereof) of transfusions in orthopedic surgery.
Traditionally, a transfusion trigger of 100 g/L has been recommended in the postoperative period, especially in older patients and in those with serious comorbidities. In the Transfusion Requirements in Critical Care trial, a much lower transfusion threshold (70 g/L) was adopted in the group of patients in whom transfusions were restricted. This prospective randomized trial that included 838 patients, is, to this day, the most important in the field and generated unexpected results. Serious morbidity (cardiac and respiratory in particular) and mortality were not increased by the adoption of a low transfusion trigger while the number of transfusions was decreased significantly.
On the other hand, it is common to observe fatigue, decreased exercise capacity and muscle strength, and impaired performance of activities of daily life in the presence of anemia, especially when the hemoglobin concentration decreases below 90 - 100 g/L. In orthopedic surgery, a decrease in "postoperative vigor" can prevent patients from undertaking the rehabilitation program required to improve functional recovery after hip fracture repair.
The objective of our research program is to determine the transfusion threshold required to maximize functional recovery after major orthopedic surgery (total hip/knee replacement) in these, most often, elderly patient with serious comorbidities.
- Conditions
- Total Hip or Knee Arthroplasty
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Observational study.
| Study group | Role | What they receive |
|---|---|---|
| Observation | Patients undergoing isolated elective total hip or knee arthroplasty (primary or revision surgery for a non-malignant condition), aged 60 years or older and able to walk prior to surgery. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance walked in 6 minutes after the operation. This is a simple, objective and reliable measure of functional recovery.
Measured: 4 to 6 days after surgery
Secondary outcomes (4)
Fatigue, dizziness, difficulty to mobilize, difficulty/inability to participate in physiotherapy, prolonged hospital stay, major adverse events (especially cardiac, respiratory, neurological or infectious), death, impact of anemia on quality of life.
Measured: up to 4-6 days after surgery
Long-term functional status
Measured: 12 months following surgery
Long-term quality of life
Measured: 12 months following surgery
Long-term complications related to perioperative anemia
Evidence of myocardial ischemia, respiratory tract infections or other majors infections
Measured: 12 months following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2008 (estimated)
- Study startMay 2008
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip or Knee ArthroplastyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Sponsor type
- University, hospital or other
- Investigators
- Jean-François Hardy, MD, FRCPC, Principal investigator, Centre Hospitalier Université Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00726349
- Sponsor's protocol ID
- HD 06.084
- Acronym
- TRIOS
- Status last verified
- May 2011
- First submitted
- 29 Jul 2008
- Last updated
- 5 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transfusion Requirements in Orthopedic Surgery (Phase 2): A Prospective Observational Evaluation of the Optimal Transfusion Trigger.
- ClinicalTrials.gov ID
- NCT00726349
- Acronym / sponsor ID
- TRIOS / HD 06.084
- Conditions
- Total Hip or Knee Arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- May 2008
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 31 Jul 2008 (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 objective of our research program is to determine the transfusion threshold required to maximize functional recovery after major orthopedic surgery (total hip/knee replacement) in these, most often, elderly patient with serious comorbidities.
Hypothesis: we hypothesize that a threshold hemoglobin concentration exists below which functional recovery becomes difficult, even if the vital prognosis of patients is not impaired.
Detailed description
Anemia is frequent after a surgical procedure. Postoperative anemia is associated with an increased incidence of transfusions and, probably, with an increased incidence of morbidity and mortality. However, the majority of studies evaluating the consequences of postoperative anemia are retrospective and, since anemic patients were transfused, they are unable to distinguish between the effects of anemia per se and those of transfusion. In orthopedic surgery, only two randomized controlled trials (RCT) have attempted to determine the benefits of transfusions in this patient population. The first evaluated the benefits of allogeneic transfusions in patients undergoing surgery for a fractured hip while the second evaluated autologous transfusions in patients undergoing total knee replacement. The small number of patients included in both studies did not allow definitive conclusions on the benefits (or lack thereof) of transfusions in orthopedic surgery.
Traditionally, a transfusion trigger of 100 g/L has been recommended in the postoperative period, especially in older patients and in those with serious comorbidities. In the Transfusion Requirements in Critical Care trial, a much lower transfusion threshold (70 g/L) was adopted in the group of patients in whom transfusions were restricted. This prospective randomized trial that included 838 patients, is, to this day, the most important in the field and generated unexpected results. Serious morbidity (cardiac and respiratory in particular) and mortality were not increased by the adoption of a low transfusion trigger while the number of transfusions was decreased significantly.
On the other hand, it is common to observe fatigue, decreased exercise capacity and muscle strength, and impaired performance of activities of daily life in the presence of anemia, especially when the hemoglobin concentration decreases below 90 - 100 g/L. In orthopedic surgery, a decrease in "postoperative vigor" can prevent patients from undertaking the rehabilitation program required to improve functional recovery after hip fracture repair.
The objective of our research program is to determine the transfusion threshold required to maximize functional recovery after major orthopedic surgery (total hip/knee replacement) in these, most often, elderly patient with serious comorbidities.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | – | Other: No interventionPatients undergoing isolated elective total hip or knee arthroplasty (primary or revision surgery for a non-malignant condition), aged 60 years or older and able to walk prior to surgery. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing isolated elective total hip or knee arthroplasty (primary or revision surgery for a non-malignant condition), aged 60 years or older and able to walk prior to surgery.
Key inclusion criteria (1 listed)
- Patients undergoing isolated elective total hip or knee arthroplasty (primary or revision surgery for a non-malignant condition), aged 60 years or older and able to walk prior to surgery.
Key exclusion criteria (1 listed)
- Since this an observational study, all patients conforming to inclusion criteria will be included.
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 |
|---|---|---|
| No interventionObservational study. | Other | Observation |
Primary outcome
Distance walked in 6 minutes after the operation. This is a simple, objective and reliable measure of functional recovery.
Time frame: 4 to 6 days after surgery
4 secondary outcomes
Fatigue, dizziness, difficulty to mobilize, difficulty/inability to participate in physiotherapy, prolonged hospital stay, major adverse events (especially cardiac, respiratory, neurological or infectious), death, impact of anemia on quality of life.
Time frame: up to 4-6 days after surgery
Long-term functional status
Time frame: 12 months following surgery
Long-term quality of life
Time frame: 12 months following surgery
Long-term complications related to perioperative anemia
Time frame: 12 months following surgery
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 5 May 2011.
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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.
Jean-François Hardy, MD, FRCPC principal investigator
Centre Hospitalier Université Montréal
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 Total Hip or Knee Arthroplasty, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 5 May 2011. 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 Canada. 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?
Distance walked in 6 minutes after the operation. This is a simple, objective and reliable measure of functional recovery. (time frame: 4 to 6 days after surgery). 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 5 May 2011.