Analysis of Blood During Surgery for Musculoskeletal Tumors

NCT01682252 | Terminated

• 1 other identifier: 01201000247
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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

Conditions

Musculoskeletal Tumors

Outcome Measures

Primary Outcomes (1)

• presence of tumor cells in the operative field

  specimens taken twice from operative field; once just prior to removal of tumor and the second just after tumor removal.

  intraoperatively

Study Arms (1)

musculoskeletal tumors

all patients undergoing surgery for musculoskeletal tumors

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

all patients undergoing orthopedic surgery for remival of musculoskeletal tumors under general anesthesia

You may qualify if:

• all patients undergoing orthopedic surgery for musculoskeletal tumors

You may not qualify if:

• pts who are pregnant

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

University Hospital

Newark, New Jersey, 07101, United States

Location

Study Officials

• Yuriy Gubenko, MD

  UMDNJ/NJMS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Yuriy Gubenko, MD Assistant Professor

Study Record Dates

• First Submitted: September 5, 2012
• First Posted: September 10, 2012
• Study Start: May 1, 2012
• Primary Completion: November 1, 2015
• Study Completion: February 1, 2016
• Last Updated: February 9, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)