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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

September 8, 2005
August 29, 2011
January 2004
Not Provided
  • Postoperative Functional mobility
  • Restricting factors for functional mobility
Same as current
Complete list of historical versions of study NCT00162617 on ClinicalTrials.gov Archive Site
  • Length of stay
  • Complications
  • Dizziness
  • Exhaustion
  • Haematoma (leg swelling)
Same as current
Not Provided
Not Provided
 
The Effect of Liberal vs. Restrictive Transfusion Strategies on Rehabilitation After Hip Fracture Surgery
The Effect of Liberal vs. Restrictive Transfusion Strategies on Rehabilitation After Hip Fracture Surgery

To examine the effect of two different transfusion regimens on rehabilitation after hip fracture surgery.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Hip Fracture
Drug: Red blood cell transfusion
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
March 2006
Not Provided

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.
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00162617
HHSG-RCT-03
Not Provided
Not Provided
Hvidovre University Hospital
IMK Fonden
Study Director: Nicolai B Foss, MD Hvidovre University Hospital
Hvidovre University Hospital
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP