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 IV

Further Study Details: 

Primary Outcomes: Postoperative Functional mobility; Restricting factors for functional mobility
Secondary Outcomes: Length of stay; Complications; Dizziness; Exhaustion; Haematoma (leg swelling)
Expected Total Enrollment:  120

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.

Ages Eligible for Study:  65 Years and above,  Genders Eligible for Study:  Both

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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00162617

Nicolai B Foss, MD      0045 36323125    nicolai.bang.foss@hh.hosp.dk

Denmark
      Hvidovre University Hospital, Hvidovre,  2650,  Denmark; Recruiting

Study chairs or principal investigators

Nicolai B Foss, MD,  Study Director,  Hvidovre University Hospital   

Study ID Numbers:  HHSG-RCT-03
Last Updated:  September 12, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00162617
Health Authority: Denmark: National Board of Health
ClinicalTrials.gov processed this record on 2005-09-13