PancreaticoduodenectomyCellsaverNCT00708513
Intraoperative Cell Saver Autotransfusion Use for Major Surgical Oncology Operations.
An observational study of Pancreaticoduodenectomy and Pancreatectomy, run by University of Louisville at 2 sites in United States.
Trial summary
The purpose of this study is to demonstrate the safety and benefit of auto-transfusion filtered blood in patients undergoing major surgical oncology procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreaticoduodenectomy, Pancreatectomy, Esophagectomy
- How many people
- 98 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2003to Dec 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Surgical Oncology Clinic
Who may be able to join
- Subject is undergoing a major surgical oncology procedure and has potential for extensive blood loss.
- Subject is ≥ 18 years of age.
- Subject or Subject's Legally Authorized Representative (LAR) has signed an IRB-approved informed consent form.
Who cannot join
- Subject has medical, social, or psychological factors that, in the opinion of the Investigator, could impact safety or compliance with study procedures.
- Subject is < 18 years of age.
- Subject or Subject's LAR did not sign IRB-approved informed consent form.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Norton Healthcare
Louisville, Kentucky, 40202
University of Louisville Hospital
Louisville, Kentucky, 40202
About this study
Official title: Phase I/II Evaluation of Intraoperative Autotransfusion Filtration for Major Surgical Oncology Operations
The purpose of this study is to demonstrate the safety and benefit of auto-transfusion filtered blood in patients undergoing major surgical oncology procedures.
Read the detailed description
Homologous blood transfusions during surgical procedures are becoming more challenging, due to lack of adequate reserves and the significant risks of transfusion reactions. Recent advances in the use of patient's own blood (autologous transfusion) has rapidly gained acceptance in major surgical procedures, however due to the requirement for prior planning and the expense of obtaining and storing a patient's blood prior to surgery this alternative is less than ideal.
This research study utilizes a third alternative, a technique called intraoperative autotransfusion, which successfully salvages a patient's blood during surgery and reinfuses the blood back into the patient. The blood salvaging device uses a filtration device that successfully filters out all tumor cells to prevent re-infusion of viable cancer cells.
This study is designed to demonstrate the safety and benefits of the blood salvaging device on patients undergoing major surgical oncology procedures.
- Conditions
- Pancreaticoduodenectomy, Pancreatectomy, Esophagectomy, Gastrectomy, Hepatectomy
- Keywords
- Cell Saver, Liver Tumors, Liver Cancer, Surgical Oncology, Whipple, Blood Transfusion, Blood salvage, cancer surgery, blood loss
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms, Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the efficacy of intra-operative ultrasound contrast (Definity) administration
Measured: Hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2008 (estimated)
- Study startDec 2003
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreaticoduodenectomyStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert C. Martin, University of Louisville
- Investigators
- Robert CG Martin, MD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00708513
- Sponsor's protocol ID
- Cell Saver 704.03
- Acronym
- Cellsaver
- Status last verified
- Oct 2013
- First submitted
- 27 Jun 2008
- Last updated
- 21 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Evaluation of Intraoperative Autotransfusion Filtration for Major Surgical Oncology Operations
- ClinicalTrials.gov ID
- NCT00708513
- Acronym / sponsor ID
- Cellsaver / Cell Saver 704.03
- Conditions
- Pancreaticoduodenectomy, Pancreatectomy, Esophagectomy, Gastrectomy, Hepatectomy
- Keywords
- Cell Saver, Liver Tumors, Liver Cancer, Surgical Oncology, Whipple, Blood Transfusion, Blood salvage, cancer surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- Dec 2003
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 2 Jul 2008 (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.
The purpose of this study is to demonstrate the safety and benefit of auto-transfusion filtered blood in patients undergoing major surgical oncology procedures.
Detailed description
Homologous blood transfusions during surgical procedures are becoming more challenging, due to lack of adequate reserves and the significant risks of transfusion reactions. Recent advances in the use of patient's own blood (autologous transfusion) has rapidly gained acceptance in major surgical procedures, however due to the requirement for prior planning and the expense of obtaining and storing a patient's blood prior to surgery this alternative is less than ideal.
This research study utilizes a third alternative, a technique called intraoperative autotransfusion, which successfully salvages a patient's blood during surgery and reinfuses the blood back into the patient. The blood salvaging device uses a filtration device that successfully filters out all tumor cells to prevent re-infusion of viable cancer cells.
This study is designed to demonstrate the safety and benefits of the blood salvaging device on patients undergoing major surgical oncology procedures.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Surgical Oncology Clinic
Key inclusion criteria (3 listed)
- Subject is undergoing a major surgical oncology procedure and has potential for extensive blood loss.
- Subject is ≥ 18 years of age.
- Subject or Subject's Legally Authorized Representative (LAR) has signed an IRB-approved informed consent form.
Key exclusion criteria (3 listed)
- Subject has medical, social, or psychological factors that, in the opinion of the Investigator, could impact safety or compliance with study procedures.
- Subject is < 18 years of age.
- Subject or Subject's LAR did not sign IRB-approved informed consent form.
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
Evaluate the efficacy of intra-operative ultrasound contrast (Definity) administration
Time frame: Hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2013.
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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.
Robert CG Martin, MD principal investigator
University of Louisville
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreaticoduodenectomy and Pancreatectomy, run by University of Louisville at 2 sites 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 21 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluate the efficacy of intra-operative ultrasound contrast (Definity) administration (time frame: Hospital discharge). 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 21 Oct 2013.