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

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ClinicalTrials.gov Identifier: NCT00162617
Recruitment Status : Unknown
Verified September 2006 by Hvidovre University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : September 13, 2005
Last Update Posted : August 30, 2011
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
To examine the effect of two different transfusion regimens on rehabilitation after hip fracture surgery.

Condition or disease Intervention/treatment Phase
Hip Fracture Drug: Red blood cell transfusion Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
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
Study Start Date : January 2004
Estimated Study Completion Date : March 2006

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U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Postoperative Functional mobility
  2. Restricting factors for functional mobility

Secondary Outcome Measures :
  1. Length of stay
  2. Complications
  3. Dizziness
  4. Exhaustion
  5. Haematoma (leg swelling)

Eligibility Criteria

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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

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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 Posted: September 13, 2005    Key Record Dates
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