Back to resultsThe Effect of Liberal vs. Restrictive Transfusion Strategies on Rehabilitation After Hip Fracture Surgery
Primary Purpose
Hip Fracture
Status
Unknown status
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Red blood cell transfusion
Sponsored by
About this trial
This is an interventional treatment trial for Hip Fracture focused on measuring Hip fracture, Rehabilitation, Transfusion, Outcome
Eligibility Criteria
Inclusion Criteria: Primary hip fracture capable of informed consent independently dwelling able to ambulate independent of human assistance no active heart condition defined as no AMI within 3 months, no unstable angina or present incompensation/pulmonary oedema no regular transfusion demand or terminal disease. Exclusion Criteria: Multiple fractures postop. immobilization due to to surgical reasons patient refusal to participate in relevant rehabilitation reoperation within 4. postoperative day.
Sites / Locations
- Hvidovre University Hospital
Outcomes
Primary Outcome Measures
Postoperative Functional mobility
Restricting factors for functional mobility
Secondary Outcome Measures
Length of stay
Complications
Dizziness
Exhaustion
Haematoma (leg swelling)
Full Information
NCT ID
NCT00162617
First Posted
September 8, 2005
Last Updated
August 29, 2011
Sponsor
Hvidovre University Hospital
Collaborators
IMK Fonden
1. Study Identification
Unique Protocol Identification Number
NCT00162617
Brief Title
The Effect of Liberal vs. Restrictive Transfusion Strategies on Rehabilitation After Hip Fracture Surgery
Official Title
The Effect of Liberal vs. Restrictive Transfusion Strategies on Rehabilitation After Hip Fracture Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Unknown status
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hvidovre University Hospital
Collaborators
IMK Fonden
4. Oversight
5. Study Description
Brief Summary
To examine the effect of two different transfusion regimens on rehabilitation after hip fracture surgery.
Detailed Description
The effect of liberal vs restrictive transfusion regimens after hip fracture surgery is unresolved. Liberal transfusion regimens (transfusion trigger hgb. 6.25 mmol/l) leads to an increased use of blood products but may impact positively on rehabilitation outcome, a restrictive transfusion trigger (hbg. 5.0 mmol/l) saves blood products but may also impair postoperative rehabilitation and outcome. the study randomizes 120 elderly patients with hip fractures to either a restrictive or a liberal perioperative transfusion therapy and measures postoperative rehabilitation outcomes within a well defined multimodal rehabilitation regimen.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture
Keywords
Hip fracture, Rehabilitation, Transfusion, Outcome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
120 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Red blood cell transfusion
Primary Outcome Measure Information:
Title
Postoperative Functional mobility
Title
Restricting factors for functional mobility
Secondary Outcome Measure Information:
Title
Length of stay
Title
Complications
Title
Dizziness
Title
Exhaustion
Title
Haematoma (leg swelling)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary hip fracture
capable of informed consent
independently dwelling
able to ambulate independent of human assistance
no active heart condition defined as no AMI within 3 months, no unstable angina or present incompensation/pulmonary oedema
no regular transfusion demand or terminal disease.
Exclusion Criteria:
Multiple fractures
postop. immobilization due to to surgical reasons
patient refusal to participate in relevant rehabilitation
reoperation within 4. postoperative day.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolai B Foss, MD
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Hvidovre University Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
34932836
Citation
Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.
Results Reference
derived
PubMed Identifier
19389209
Citation
Foss NB, Kristensen MT, Jensen PS, Palm H, Krasheninnikoff M, Kehlet H. The effects of liberal versus restrictive transfusion thresholds on ambulation after hip fracture surgery. Transfusion. 2009 Feb;49(2):227-34. doi: 10.1111/j.1537-2995.2008.01967.x.
Results Reference
derived
Learn more about this trial
The Effect of Liberal vs. Restrictive Transfusion Strategies on Rehabilitation After Hip Fracture Surgery
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