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Analysis of Blood During Surgery for Musculoskeletal Tumors

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ClinicalTrials.gov Identifier: NCT01682252
Recruitment Status : Terminated (investigators felt sufficient data has been collected)
First Posted : September 10, 2012
Last Update Posted : February 9, 2016
Sponsor:
Information provided by (Responsible Party):
Anesthesia, Rutgers, The State University of New Jersey

Brief Summary:
This study is being done as the doctor investigators would like to lessen the amount of blood transfusions given to patients. Patients who receive blood transfusions have a greater chance of developing complications after surgery. There is a device called the Cell Saver that allows the doctors to process blood that is lost during surgery and return it to the patient. This lessens the amount of transfused blood the patients receive. This device is not used for patients undergoing surgery for muscular skeletal tumors.The investigators are not sure whether tumor cells are present in the blood which is lost during the course of an operation like yours. The goal of this study is to see if we lessen the amount of blood transfusions given to patients who may have tumor or cancerous cells present in their blood. One way to do this is to test the blood that is circulating in your veins and also to test the blood which is lost during the course of your operation

Condition or disease
Musculoskeletal Tumors

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 34 participants
Time Perspective: Prospective
Official Title: Cellular Analysis of Blood Suctioned During Surgery for Musculoskeletal Tumors
Study Start Date : May 2012
Actual Primary Completion Date : November 2015
Actual Study Completion Date : February 2016

Group/Cohort
musculoskeletal tumors
all patients undergoing surgery for musculoskeletal tumors



Primary Outcome Measures :
  1. presence of tumor cells in the operative field [ Time Frame: intraoperatively ]
    specimens taken twice from operative field; once just prior to removal of tumor and the second just after tumor removal.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
all patients undergoing orthopedic surgery for remival of musculoskeletal tumors under general anesthesia
Criteria

Inclusion Criteria:

  • all patients undergoing orthopedic surgery for musculoskeletal tumors

Exclusion Criteria:

  • pts who are pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01682252


Locations
United States, New Jersey
University Hospital
Newark, New Jersey, United States, 07101
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
Principal Investigator: Yuriy Gubenko, MD UMDNJ/NJMS

Responsible Party: Anesthesia, Yuriy Gubenko, MD Assistant Professor, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01682252     History of Changes
Other Study ID Numbers: 01201000247
First Posted: September 10, 2012    Key Record Dates
Last Update Posted: February 9, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No