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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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00162617
Enrollment
120
Registered
2005-09-13
Start date
2004-01-31
Completion date
2006-03-31
Last updated
2011-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Fracture

Keywords

Hip fracture, Rehabilitation, Transfusion, Outcome

Brief summary

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

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.

Interventions

DRUGRed blood cell transfusion

Sponsors

IMK Fonden
CollaboratorOTHER
Hvidovre University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Postoperative Functional mobility
Restricting factors for functional mobility

Secondary

MeasureTime frame
Dizziness
Length of stay
Haematoma (leg swelling)
Exhaustion
Complications

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026