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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00749710
Enrollment
100
Registered
2008-09-09
Start date
2008-09-30
Completion date
2012-12-31
Last updated
2008-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antiaggregant Therapy, Femoral Neck Fractures, Pertrochanteric Fractures

Keywords

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

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.

Interventions

PROCEDUREclopidogrel

ORIF - surgical treatment

PROCEDUREno antiaggregant therapy

ORIF - surgical treatment

Sponsors

Tel-Aviv Sourasky Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
mortality 30 days, 1 year functional score 1 year blood loss at surgery blood transfusions during hospitalization wound complications1 year

Contacts

Primary ContactEly Steinberg, MD
steinberge@tasmc.health.gov.il972-52-4266346
Backup Contactofir chechik, MD
ofirchik@yahoo.com972-52-2653820

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026