Analysis of Blood During Surgery for Musculoskeletal Tumors
This study is currently recruiting participants.
Verified September 2012 by University of Medicine and Dentistry New Jersey
Sponsor:
Information provided by (Responsible Party):
Anesthesia, University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT01682252
First received: September 5, 2012
Last updated: NA
Last verified: September 2012
History: No changes posted
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
| Study Type: |
Observational
|
| Study Design: |
Time Perspective: Prospective |
| Official Title: |
Cellular Analysis of Blood Suctioned During Surgery for Musculoskeletal Tumors |
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: |
July 2013 |
| Estimated Primary Completion Date: |
January 2013 (Final data collection date for primary outcome measure) |
|
musculoskeletal tumors
all patients undergoing surgery for musculoskeletal tumors
|
| Ages Eligible for Study: |
18 Years to 90 Years |
| Genders Eligible for Study: |
Both |
| Accepts Healthy Volunteers: |
No |
| Sampling Method: |
Probability Sample |
all patients undergoing orthopedic surgery for remival of musculoskeletal tumors under general anesthesia
Inclusion Criteria:
- all patients undergoing orthopedic surgery for musculoskeletal tumors
Exclusion Criteria:
Please refer to this study by its ClinicalTrials.gov identifier: NCT01682252
|
| University Hospital |
| 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 |
University of Medicine and Dentistry New Jersey
| Principal Investigator: |
Yuriy Gubenko, MD |
UMDNJ/NJMS |
No publications provided
| Responsible Party: |
Anesthesia, Yuriy Gubenko, MD Assistant Professor, University of Medicine and Dentistry New Jersey |
| ClinicalTrials.gov Identifier: |
NCT01682252
History of Changes
|
| Other Study ID Numbers: |
01201000247 |
| Study First Received: |
September 5, 2012 |
| Last Updated: |
September 5, 2012 |
| Health Authority: |
United States: Food and Drug Administration
|
ClinicalTrials.gov processed this record on May 16, 2013
