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

Femoral Neck Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00749710
• Other study ID #: TASMC-08-ES-143-CTIL
• Secondary ID: non
• Status: Not yet recruiting
• Phase: N/A
• First received: September 8, 2008
• Last updated: September 8, 2008
• Start date: September 2008
• Est. completion date: December 2012

Study information

• Verified date: September 2008
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Ely Steinberg, MD
• Phone: 972-52-4266346
• Email: steinberge[@]tasmc.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Antiaggregant Therapy
• Femoral Neck Fractures
• Fractures, Bone
• Pertrochanteric Fractures

Intervention

Procedure:
• clopidogrel
ORIF - surgical treatment
• no antiaggregant therapy
ORIF - surgical treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

References & Publications (1)

Wehren LE, Magaziner J. Hip fracture: risk factors and outcomes. Curr Osteoporos Rep. 2003 Sep;1(2):78-85. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality 30 days, 1 year functional score 1 year blood loss at surgery blood transfusions during hospitalization wound complications		1 year	Yes