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

Hvidovre University Hospital

Status and phase: Unknown; Phase 4

Conditions: Hip Fracture

Treatments: Drug: Red blood cell transfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT00162617

HHSG-RCT-03

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind