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The Effect of Liberal vs. Restrictive Transfusion Strategies on Rehabilitation After Hip Fracture Surgery

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2006 by Hvidovre University Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00162617
First Posted: September 13, 2005
Last Update Posted: August 30, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
IMK Fonden
Information provided by:
Hvidovre University Hospital
  Purpose
To examine the effect of two different transfusion regimens on rehabilitation after hip fracture surgery.

Condition Intervention Phase
Hip Fracture Drug: Red blood cell transfusion Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Effect of Liberal vs. Restrictive Transfusion Strategies on Rehabilitation After Hip Fracture Surgery

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Postoperative Functional mobility
  • Restricting factors for functional mobility

Secondary Outcome Measures:
  • Length of stay
  • Complications
  • Dizziness
  • Exhaustion
  • Haematoma (leg swelling)

Estimated Enrollment: 120
Study Start Date: January 2004
Estimated Study Completion Date: March 2006
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00162617


Locations
Denmark
Hvidovre University Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
IMK Fonden
Investigators
Study Director: Nicolai B Foss, MD Hvidovre University Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00162617     History of Changes
Other Study ID Numbers: HHSG-RCT-03
First Submitted: September 8, 2005
First Posted: September 13, 2005
Last Update Posted: August 30, 2011
Last Verified: September 2006

Keywords provided by Hvidovre University Hospital:
Hip fracture
Rehabilitation
Transfusion
Outcome

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries