Transfusion Requirements in Orthopedic Surgery (PHASE 2) (TRIOS)

This study has been completed.
Sponsor:
Information provided by:
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT00726349
First received: July 29, 2008
Last updated: May 4, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention
Total Hip or Knee Arthroplasty
Other: No intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Transfusion Requirements in Orthopedic Surgery (Phase 2): A Prospective Observational Evaluation of the Optimal Transfusion Trigger.

Resource links provided by NLM:


Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Long-term functional status [ Time Frame: 12 months following surgery ] [ Designated as safety issue: No ]
  • Long-term quality of life [ Time Frame: 12 months following surgery ] [ Designated as safety issue: No ]
  • Long-term complications related to perioperative anemia [ Time Frame: 12 months following surgery ] [ Designated as safety issue: Yes ]
    Evidence of myocardial ischemia, respiratory tract infections or other majors infections


Enrollment: 305
Study Start Date: May 2008
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Other: No intervention
Observational study.

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Since this an observational study, all patients conforming to inclusion criteria will be included.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00726349

Locations
Canada, Quebec
CHUM-Hôpital Notre-Dame
Montreal, Quebec, Canada, H2L 4M1
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
Principal Investigator: Jean-François Hardy, MD, FRCPC Centre Hospitalier Université Montréal
  More Information

No publications provided

Responsible Party: Dr Jean-François Hardy, Centre de recherche du CHUM (CRCHUM)
ClinicalTrials.gov Identifier: NCT00726349     History of Changes
Other Study ID Numbers: HD 06.084
Study First Received: July 29, 2008
Last Updated: May 4, 2011
Health Authority: Canada: Ethics Review Committee

ClinicalTrials.gov processed this record on April 21, 2014