Analysis of Blood During Surgery for Musculoskeletal Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Rutgers, The State University of New Jersey
Sponsor:
Information provided by (Responsible Party):
Anesthesia, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT01682252
First received: September 5, 2012
Last updated: October 7, 2014
Last verified: October 2014
  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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • presence of tumor cells in the operative field [ Time Frame: intraoperatively ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: May 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
musculoskeletal tumors
all patients undergoing surgery for musculoskeletal tumors

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
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: NCT01682252

Contacts
Contact: Yuriy Gubenko, MD 973 972-5007 yuriygubenko@yahoo.com
Contact: Catherine Schoenberg, BSN 973 972-7477 shoenbce@umdnj.edu

Locations
United States, New Jersey
University Hospital Recruiting
Newark, New Jersey, United States, 07101
Contact: Yuriy Gubenko, MD    973-972-5007    yuriygubenko@yahoo.com   
Contact: Catherine Schoenberg, BSN    973 972-7477    shoenbce@umdnj.edu   
Principal Investigator: Yuriy Gubenko, MD         
Sub-Investigator: Francis Patterson, MD         
Sub-Investigator: Sheldon Goldstein, MD         
Sub-Investigator: Valerie Fitzhugh, MD         
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
Principal Investigator: Yuriy Gubenko, MD UMDNJ/NJMS
  More Information

No publications provided

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
Study First Received: September 5, 2012
Last Updated: October 7, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 21, 2014