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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2006-03-31

Brief Summary

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

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RECRUITING

Detailed Description

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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.

Conditions

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Hip Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Red blood cell transfusion

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No