This trial is active, not recruiting.

Condition hip fracture
Treatment red blood cell transfusion
Phase phase 4
Sponsor Hvidovre University Hospital
Collaborator IMK Fonden
Start date January 2004
End date March 2006
Trial size 120 participants
Trial identifier NCT00162617, HHSG-RCT-03


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

Postoperative Functional mobility
time frame:
Restricting factors for functional mobility
time frame:

Secondary Outcomes

Length of stay
time frame:
time frame:
time frame:
time frame:
Haematoma (leg swelling)
time frame:

Eligibility Criteria

Male or female participants at least 65 years old.

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.

Additional Information

Official title The Effect of Liberal vs. Restrictive Transfusion Strategies on Rehabilitation After Hip Fracture Surgery
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2011.
Information provided to ClinicalTrials.gov by Hvidovre University Hospital.