- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00162617
The Effect of Liberal vs. Restrictive Transfusion Strategies on Rehabilitation After Hip Fracture Surgery
August 29, 2011 updated by: Hvidovre University Hospital
To examine the effect of two different transfusion regimens on rehabilitation after hip fracture surgery.
Study Overview
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.
Study Type
Interventional
Enrollment
120
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hvidovre, Denmark, 2650
- Hvidovre University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Postoperative Functional mobility
|
Restricting factors for functional mobility
|
Secondary Outcome Measures
Outcome Measure |
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Complications
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Length of stay
|
Dizziness
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Exhaustion
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Haematoma (leg swelling)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Nicolai B Foss, MD, Hvidovre University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Dorée C, Hébert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12:CD002042. doi: 10.1002/14651858.CD002042.pub5. Review.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2004
Study Completion
March 1, 2006
Study Registration Dates
First Submitted
September 8, 2005
First Submitted That Met QC Criteria
September 11, 2005
First Posted (Estimate)
September 13, 2005
Study Record Updates
Last Update Posted (Estimate)
August 30, 2011
Last Update Submitted That Met QC Criteria
August 29, 2011
Last Verified
September 1, 2006
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HHSG-RCT-03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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