Blood Loss and Complications of Internal Fixation of Femoral Neck Fractures in Patients Treated With Clopidogrel

Tel Aviv Sourasky Medical Center

Status: Unknown

Conditions: Antiaggregant Therapy; Femoral Neck Fractures; Pertrochanteric Fractures

Treatments: Procedure: no antiaggregant therapy; Procedure: clopidogrel

Study type: Interventional

Funder types: Other

Identifiers

NCT00749710

non

TASMC-08-ES-143-CTIL

Details and patient eligibility

About

Patients suffering from femoral neck or pertrochanteric fractures have a high rate of mortality and morbidity associated mainly with deconditioning and immobilization. Surgical management including open reduction and internaql fixation has been shown to reduce complication and improve outcome in such patients. Delay of surgery produces less optimal results and is associated with higher morbidity even after 24-48 hours of fracture event.

Patients treated with platelet antiaggregants are exposed to higher blood loss during surgery and related complications, as demonstrated in patients treated with Aspirin. However, cessation of antiaggregant therapy before surgery may be associated with complications of a hypercoagulable state and surgery delay.

Clpopidogrel is a fairly new approved antiaggregant drug indicated in cases of failed aspirin treatment in ischemic heart disease and cerebrovascular disease patients as well as in primary prevention of stent restenosis.

No data regarding complications of hip surgery in patients treated with Clpopidogrel is available.

Study hypothesis:

Definitive surgical treatment of patients treated with clopidogrel undergoing open reduction and internal fixation of pertrochnteric and femoral neck fractures is safe although associated with more extensive blood loss during surgery and postoperative wound complications.

Enrollment: 100 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age > 60
• pertrochanteric or femoral neck fracture within 48 hours
• clopidogrel treatment - study group
• no antiaggregant treatment - control group
• ASA score <=3

Exclusion criteria

• hematologic malignancy
• hematologic malfunction
• warfarin treatment
• previous active GI or other internal bleeding - within 1 year
• thrombocytopenia < 150

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

1

Active Comparator group

Description:

immediate operation - ORIF - of hip fracture in patient treated with clopidogrel

Treatment:

Procedure: clopidogrel

2

Active Comparator group

Description:

ORIF - surgical treatment patients not on antiaggregant therapy

Treatment:

Procedure: no antiaggregant therapy