Blood Loss and Complications of Internal Fixation of Femoral Neck Fractures in Patients Treated With Clopidogrel
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Femoral Neck Fractures Pertrochanteric Fractures Antiaggregant Therapy |
Procedure: clopidogrel Procedure: no antiaggregant therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Blood Loss and Complications of Internal Fixation of Femoral Neck Fractures in Patients Treated With Clopidogrel |
- mortality 30 days, 1 year functional score 1 year blood loss at surgery blood transfusions during hospitalization wound complications [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 100 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
immediate operation - ORIF - of hip fracture in patient treated with clopidogrel
|
Procedure: clopidogrel
ORIF - surgical treatment
|
|
Active Comparator: 2
ORIF - surgical treatment patients not on antiaggregant therapy
|
Procedure: no antiaggregant therapy
ORIF - surgical treatment
|
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Contact: Ely Steinberg, MD | 972-52-4266346 | steinberge@tasmc.health.gov.il |
| Contact: ofir chechik, MD | 972-52-2653820 | ofirchik@yahoo.com |
| Principal Investigator: | Ely Steinberg, MD | Tel-Aviv Sourasky Medical Center |
More Information
Publications:
| Responsible Party: | Steinberg Ely MD, Tel-Aviv Sourasky Medical Center |
| ClinicalTrials.gov Identifier: | NCT00749710 History of Changes |
| Other Study ID Numbers: | TASMC-08-ES-143-CTIL, non |
| Study First Received: | September 8, 2008 |
| Last Updated: | September 8, 2008 |
| Health Authority: | Israel: Ethics Commission |
Keywords provided by Tel-Aviv Sourasky Medical Center:
|
femoral neck fractures pertrochanteric fractures antiaggregant therapy clopidogrel plavix |
Additional relevant MeSH terms:
|
Femoral Neck Fractures Fractures, Bone Hemorrhage Hip Fractures Femoral Fractures Wounds and Injuries Leg Injuries Pathologic Processes Clopidogrel Ticlopidine Platelet Aggregation Inhibitors Hematologic Agents |
Therapeutic Uses Pharmacologic Actions Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Fibrinolytic Agents Fibrin Modulating Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 21, 2013