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Blood Management Observation in Oncology Surgical Treatment (BOOST)


N/A
18 Years
N/A
Not Enrolling
Both
Anemia, Blood Loss, Surgical, Neoplasms

Thank you

Trial Information

Blood Management Observation in Oncology Surgical Treatment (BOOST)


Considerable blood loss typically accompanies surgical procedures to remove malignant
tumors. Blood transfusions, the best method of compensating for blood loss during surgery,
have associated medical risks including infection transmission and allergic reaction, in
addition to using significant amounts of red blood cells, which are often in short supply.
Options exist to manage blood loss before surgery, including a procedure where a patient's
own blood is stored in advance to be given if needed during surgery, and drug intervention,
where a drug is given before surgery to help increase red blood cell production, thereby
maintaining hemoglobin and oxygen levels in the body during surgery. This is a multi-center
observational study to collect information regarding the methods used to manage blood loss
in patients undergoing surgical removal of malignant tumors in the Netherlands. Information
will be collected by study center and by patient over the course of approximately 18 months.
For study center information, each observation period will last 2 months and there will be
at least a 2-month interval between each observation period. For patient information there
is one continuous observation period. General information regarding the frequency of use of
different blood-saving techniques for the various types of operations performed will be
collected from each of the centers participating in the study. Data obtained at the onset
of the study will be compared to follow-up data gathered throughout the additional reporting
periods and trends or changes in frequency of use of blood-saving techniques will be noted.
The following information will be collected: medical history, tumor stage, type/site of
operation, anticipated vs. actual blood loss during surgery, most recent hemoglobin and
hematocrit values prior to the operation, blood-saving techniques used and the number of
units and types of blood transfusions up to 24 hours after the operation. Information will
be obtained from patients' medical records. No medication will be supplied by the study
Sponsor and no specific procedures will be required for the study. Each patient's surgeon
and anesthesiologist will be responsible for all decisions regarding his/her care and
treatment during the operation. Information may be collected a maximum of one time from each
patient during this study and there will be no follow-up information collected from
individual patients. Since the study involves only the collection of information, no
treatment will be required by the Sponsor and no medication will be supplied by the Sponsor.


Inclusion Criteria:



- Patients with a malignant tumor for which surgery is the first treatment

- Having an expected blood loss of at least 500 ml (100 teaspoons), and not more than
3000 ml (600 teaspoons)

Exclusion Criteria:

- Patients with a malignant tumor for which surgery is not the first treatment (i.e.
have received chemotherapy first)

- Inability to speak, read and write Dutch

Type of Study:

Observational

Study Design:

Time Perspective: Cross-Sectional

Outcome Measure:

Patients' medical history; tumor stage; type/site of operation; anticipated vs. actual blood loss; hemoglobin/hematocrit values prior to surgery, blood-saving techniques used; number of units and types of blood transfusions up to 24 hours after surgery

Outcome Time Frame:

24 hours after surgery

Safety Issue:

No

Principal Investigator

Janssen-Cilag B.V. Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen-Cilag B.V.

Authority:

Netherlands: Netherlands Medicines Evaluation Board

Study ID:

CR003460

NCT ID:

NCT00264095

Start Date:

July 2004

Completion Date:

February 2006

Related Keywords:

  • Anemia
  • Blood Loss, Surgical
  • Neoplasms
  • Anemia
  • Blood loss
  • Transfusion
  • Blood transfusion
  • Erythropoietin
  • Surgery
  • Surgical blood loss
  • Tumor
  • Cancer
  • Surgical resection
  • Tumor resection
  • Anemia
  • Neoplasms
  • Hemorrhage
  • Blood Loss, Surgical

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