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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 because the information has not been verified recently.
Verified September 2006 by Hvidovre University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
IMK Fonden
Information provided by:
Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00162617
First received: September 8, 2005
Last updated: August 29, 2011
Last verified: September 2006
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Effect of Liberal vs. Restrictive Transfusion Strategies on Rehabilitation After Hip Fracture Surgery

Resource links provided by NLM:

U.S. FDA Resources

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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Hvidovre University Hospital

Additional 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
Study First Received: September 8, 2005
Last Updated: August 29, 2011
Health Authority: Denmark: National Board of Health

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

ClinicalTrials.gov processed this record on May 23, 2013