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

Hip Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00162617
• Other study ID #: HHSG-RCT-03
• Status: Active, not recruiting
• Phase: Phase 4
• First received: September 8, 2005
• Last updated: August 29, 2011
• Start date: January 2004
• Est. completion date: March 2006

Study information

• Verified date: September 2006
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial Summary

To examine the effect of two different transfusion regimens 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fracture
• Hip Fractures

Intervention

Drug:
• Red blood cell transfusion

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital	Hvidovre

Sponsors (2)

Lead Sponsor	Collaborator
Hvidovre University Hospital	IMK Fonden

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Functional mobility
Primary	Restricting factors for functional mobility
Secondary	Length of stay
Secondary	Complications
Secondary	Dizziness
Secondary	Exhaustion
Secondary	Haematoma (leg swelling)