NCT00726349

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
305

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 31, 2008

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

May 5, 2011

Status Verified

May 1, 2011

Enrollment Period

3 years

First QC Date

July 29, 2008

Last Update Submit

May 4, 2011

Conditions

Total Hip or Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Distance walked in 6 minutes after the operation. This is a simple, objective and reliable measure of functional recovery.

    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.

    up to 4-6 days after surgery

  • Long-term functional status

    12 months following surgery

  • Long-term quality of life

    12 months following surgery

  • Long-term complications related to perioperative anemia

    12 months following surgery

Study Arms (1)

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

Interventions

No interventionOTHER

Observational study.

Observation

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHUM-Hôpital Notre-Dame

Montreal, Quebec, H2L 4M1, Canada

Location

Study Officials

  • Jean-François Hardy, MD, FRCPC

    Centre Hospitalier Université Montréal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 29, 2008

First Posted

July 31, 2008

Study Start

May 1, 2008

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

May 5, 2011

Record last verified: 2011-05

Locations

CA(1)