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

NCT00749710 | Unknown

• 2 other identifiers: TASMC-08-ES-143-CTILnon
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Femoral Neck Fractures; Pertrochanteric Fractures; Antiaggregant Therapy

Keywords

femoral neck fractures; pertrochanteric fractures; antiaggregant therapy; clopidogrel; plavix

Outcome Measures

Primary Outcomes (1)

• mortality 30 days, 1 year functional score 1 year blood loss at surgery blood transfusions during hospitalization wound complications

  1 year

Study Arms (2)

1

ACTIVE COMPARATOR

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

Procedure: clopidogrel

2

ACTIVE COMPARATOR

ORIF - surgical treatment patients not on antiaggregant therapy

Procedure: no antiaggregant therapy

Interventions

clopidogrel PROCEDURE

ORIF - surgical treatment

1

no antiaggregant therapy PROCEDURE

ORIF - surgical treatment

2

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Related Publications (1)

• Wehren LE, Magaziner J. Hip fracture: risk factors and outcomes. Curr Osteoporos Rep. 2003 Sep;1(2):78-85. doi: 10.1007/s11914-003-0013-8.

  PMID: 16036069 BACKGROUND

MeSH Terms

Conditions

Femoral Neck Fractures

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ely Steinberg, MD

  Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ely Steinberg, MD

CONTACT

972-52-4266346; steinberge@tasmc.health.gov.il

ofir chechik, MD

CONTACT

972-52-2653820; ofirchik@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 8, 2008
• First Posted: September 9, 2008
• Study Start: September 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: September 9, 2008

Record last verified: 2008-09