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Analysis of Blood During Surgery for Musculoskeletal Tumors

This study has been terminated.
(investigators felt sufficient data has been collected)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01682252
First Posted: September 10, 2012
Last Update Posted: February 9, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Anesthesia, Rutgers, The State University of New Jersey
  Purpose
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
Musculoskeletal Tumors

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Cellular Analysis of Blood Suctioned During Surgery for Musculoskeletal Tumors

Further study details as provided by Anesthesia, Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • 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.


Enrollment: 34
Study Start Date: May 2012
Study Completion Date: February 2016
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
musculoskeletal tumors
all patients undergoing surgery for musculoskeletal tumors

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

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 Submitted: September 5, 2012
First Posted: September 10, 2012
Last Update Posted: February 9, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No