Musculoskeletal TumorsNCT01682252
Analysis of Blood During Surgery for Musculoskeletal Tumors
An observational study of Musculoskeletal Tumors, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Musculoskeletal Tumors
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all patients undergoing orthopedic surgery for remival of musculoskeletal tumors under general anesthesia
Who may be able to join
- all patients undergoing orthopedic surgery for musculoskeletal tumors
Who cannot join
- pts who are pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cellular Analysis of Blood Suctioned During Surgery for Musculoskeletal Tumors
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
Read the detailed description
Allogenic Blood transfusions are associated with numerous complications from simple uticaria to serious transmissible diseases. While improved testing has significantly decreased the incidence of AIDS and hepatitis C to approximately 1:2,000,000 units tested; hepatitis B approximately 1:200,000 units tested, more frequent complications occur secondary to immunomodulation, which results in making infections more common. These are not due to infected blood, but develop because of changes in patients' immune system after having received an allogenic red blood cell transfusion. The relative risk for developing an infection is 1.6 for 1-3 red blood cell units and 3.6 for patients who receive more than 3 red cell units. Patients who receive transfusions have a 52% greater risk of developing pneumonia and a 35% greater risk of developing a urinary tract infection. On average, hospitalization costs $14,000 more for patients with a serious infection. These infections prolong the length of hospitalization after surgery and may even result in death.2 Other complications of transfusion include Transfusion Related Acute Lung Injury which causes at least 5300 TRALI reactions per year in the US alone, and approximately 500 deaths. In fact, just one donor whose blood triggered a TRALI death was found on review of records to have caused 14 previous cases of TRALI. Other serious complications include Adult Respiratory Distress Syndrome, and transfusion reactions. As a group, these complications of transfusion result in increased morbidity and mortality. Therefore, it is in the best interest of patients to decrease the amount of allogenic blood transfused (from other individuals). To prevent this, surgeons employ the use of a Cell Saver (CS) during surgery which collects the patient's own blood from the operative field and washes it. This blood is then re-infused into the patient's intravenous, minimizing the need for transfusion of blood from the blood bank.
Despite the benefits of the cell saver, it is not used in patients who have malignancy due to concern that the tumor cells may spread systemically via the blood. Due to the nature of musculoskeletal tumor resections there is often significant blood loss. Dissection is regularly through the muscles rather than around muscular intervals, which can result in significant bleeding. The goal of this study is to determine the presence or absence of tumor cells in the blood suctioned from the surgical field. Pending the outcome, consideration will be made to go forward with a second study to determine if cell saver could be used in patients with malignancy undergoing surgery.
It is unclear whether tumor cells are present in the blood suctioned from an extremity malignancy resection. It is also unknown if the processing of blood suctioned would remove tumor cells from the blood to be transfused. If no tumor cells are found in the blood after processing then transfusion of this blood would likely be safe. This could result in decreased blood transfusions in this patient population. This would not only decrease risk to these patients, it would also improve the blood supply, ensuring that blood is available for other patients who require it. This work is highly significant as it would both improve safety in this patient population and improve the blood supply. Data collected will include the patient's diagnosis, the presence or absence of metastatic disease, whether they have been previously treated with chemotherapy or radiation and the dates of that treatment. Patients will undergo surgery and anesthesia in the usual manner. Three sets of specimens approximately 4mL each would be taken; one from a peripheral line prior to opening the skin, the second sample will be taken from the surgical field or suction canister during the tumor resection the third from the surgical field or suction canister shortly before the tumor is removed. These samples will be taken to Dr. Fitzhugh's laboratory for slide staining.
Patients who are determined by their surgeon and/or anesthesiologist to require blood will be administered blood processed by the University Hospital Blood Bank using standard transfusion protocols. No blood taken from the patient or the operative field will be transfused.
There are no significant risks in this study. Roughly 2 ml of blood is required for the total number of slides (2-4) that would be prepared per tube. This amount of blood 12 mL is less than one tablespoon and does not pose significant risk to the patient nor does it increase the likelihood of transfusion. Slides will be stained using the Diff-Quik staining method, a method similar to the Wright-Giemsa staining used in hematology laboratories. The technique is rapid (requires only 3 minutes per submitted sample) and inexpensive. Slides will be reviewed by Dr. Fitzhugh.
- Conditions
- Musculoskeletal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| musculoskeletal tumors | all patients undergoing surgery for musculoskeletal tumors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2012 (estimated)
- Study startMay 2012
- Primary completionNov 2015
- Study completionFeb 2016
Why it stopped: investigators felt sufficient data has been collected
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal TumorsStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anesthesia, Rutgers, The State University of New Jersey
- Investigators
- Yuriy Gubenko, MD, Principal investigator, UMDNJ/NJMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01682252
- Sponsor's protocol ID
- 01201000247
- Status last verified
- Feb 2016
- First submitted
- 5 Sep 2012
- Last updated
- 9 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cellular Analysis of Blood Suctioned During Surgery for Musculoskeletal Tumors
- ClinicalTrials.gov ID
- NCT01682252
- Acronym / sponsor ID
- 01201000247
- Conditions
- Musculoskeletal Tumors
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: investigators felt sufficient data has been collected
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Nov 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 10 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Allogenic Blood transfusions are associated with numerous complications from simple uticaria to serious transmissible diseases. While improved testing has significantly decreased the incidence of AIDS and hepatitis C to approximately 1:2,000,000 units tested; hepatitis B approximately 1:200,000 units tested, more frequent complications occur secondary to immunomodulation, which results in making infections more common. These are not due to infected blood, but develop because of changes in patients' immune system after having received an allogenic red blood cell transfusion. The relative risk for developing an infection is 1.6 for 1-3 red blood cell units and 3.6 for patients who receive more than 3 red cell units. Patients who receive transfusions have a 52% greater risk of developing pneumonia and a 35% greater risk of developing a urinary tract infection. On average, hospitalization costs $14,000 more for patients with a serious infection. These infections prolong the length of hospitalization after surgery and may even result in death.2 Other complications of transfusion include Transfusion Related Acute Lung Injury which causes at least 5300 TRALI reactions per year in the US alone, and approximately 500 deaths. In fact, just one donor whose blood triggered a TRALI death was found on review of records to have caused 14 previous cases of TRALI. Other serious complications include Adult Respiratory Distress Syndrome, and transfusion reactions. As a group, these complications of transfusion result in increased morbidity and mortality. Therefore, it is in the best interest of patients to decrease the amount of allogenic blood transfused (from other individuals). To prevent this, surgeons employ the use of a Cell Saver (CS) during surgery which collects the patient's own blood from the operative field and washes it. This blood is then re-infused into the patient's intravenous, minimizing the need for transfusion of blood from the blood bank.
Despite the benefits of the cell saver, it is not used in patients who have malignancy due to concern that the tumor cells may spread systemically via the blood. Due to the nature of musculoskeletal tumor resections there is often significant blood loss. Dissection is regularly through the muscles rather than around muscular intervals, which can result in significant bleeding. The goal of this study is to determine the presence or absence of tumor cells in the blood suctioned from the surgical field. Pending the outcome, consideration will be made to go forward with a second study to determine if cell saver could be used in patients with malignancy undergoing surgery.
It is unclear whether tumor cells are present in the blood suctioned from an extremity malignancy resection. It is also unknown if the processing of blood suctioned would remove tumor cells from the blood to be transfused. If no tumor cells are found in the blood after processing then transfusion of this blood would likely be safe. This could result in decreased blood transfusions in this patient population. This would not only decrease risk to these patients, it would also improve the blood supply, ensuring that blood is available for other patients who require it. This work is highly significant as it would both improve safety in this patient population and improve the blood supply. Data collected will include the patient's diagnosis, the presence or absence of metastatic disease, whether they have been previously treated with chemotherapy or radiation and the dates of that treatment. Patients will undergo surgery and anesthesia in the usual manner. Three sets of specimens approximately 4mL each would be taken; one from a peripheral line prior to opening the skin, the second sample will be taken from the surgical field or suction canister during the tumor resection the third from the surgical field or suction canister shortly before the tumor is removed. These samples will be taken to Dr. Fitzhugh's laboratory for slide staining.
Patients who are determined by their surgeon and/or anesthesiologist to require blood will be administered blood processed by the University Hospital Blood Bank using standard transfusion protocols. No blood taken from the patient or the operative field will be transfused.
There are no significant risks in this study. Roughly 2 ml of blood is required for the total number of slides (2-4) that would be prepared per tube. This amount of blood 12 mL is less than one tablespoon and does not pose significant risk to the patient nor does it increase the likelihood of transfusion. Slides will be stained using the Diff-Quik staining method, a method similar to the Wright-Giemsa staining used in hematology laboratories. The technique is rapid (requires only 3 minutes per submitted sample) and inexpensive. Slides will be reviewed by Dr. Fitzhugh.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| musculoskeletal tumors | – | –all patients undergoing surgery for musculoskeletal tumors |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients undergoing orthopedic surgery for remival of musculoskeletal tumors under general anesthesia
Key inclusion criteria (1 listed)
- all patients undergoing orthopedic surgery for musculoskeletal tumors
Key exclusion criteria (1 listed)
- pts who are pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study was stopped early (reason given: investigators felt sufficient data has been collected). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuriy Gubenko, MD principal investigator
UMDNJ/NJMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Tumors, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: investigators felt sufficient data has been collected). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence of tumor cells in the operative field (time frame: intraoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2016.