Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

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

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. 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
IMK Fonden
Information provided by:
Hvidovre University Hospital

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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
Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

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)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT00162617

Layout table for location information
Hvidovre University Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
IMK Fonden
Layout table for investigator information
Study Director: Nicolai B Foss, MD Hvidovre University Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00162617    
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries