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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00749710
First received: September 8, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00749710

Contacts
Contact: Ely Steinberg, MD 972-52-4266346 steinberge@tasmc.health.gov.il
Contact: ofir chechik, MD 972-52-2653820 ofirchik@yahoo.com

Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
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 July 20, 2014