Intraoperative Cell Saver Autotransfusion Use for Major Surgical Oncology Operations.

Phase I/II Evaluation of Intraoperative Autotransfusion Filtration for Major Surgical Oncology Operations

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00708513

Acronym

Cellsaver

Enrollment

Registered

2008-07-02

Start date

2003-12-31

Completion date

2009-12-31

Last updated

2013-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophagectomy, Gastrectomy, Hepatectomy, Pancreatectomy, Pancreaticoduodenectomy

Keywords

Cell Saver, Liver Tumors, Liver Cancer, Surgical Oncology, Whipple, Blood Transfusion, Blood salvage, cancer surgery, blood loss

Brief 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.

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Subject is undergoing a major surgical oncology procedure and has potential for extensive blood loss. 2. Subject is ≥ 18 years of age. 3. Subject or Subject's Legally Authorized Representative (LAR) has signed an IRB-approved informed consent form.

Exclusion criteria

1. Subject has medical, social, or psychological factors that, in the opinion of the Investigator, could impact safety or compliance with study procedures. 2. Subject is \< 18 years of age. 3. Subject or Subject's LAR did not sign IRB-approved informed consent form.

Design outcomes

Primary

Measure	Time frame
Evaluate the efficacy of intra-operative ultrasound contrast (Definity) administration	Hospital discharge

Countries

United States

Outcome results