Clinical trial NCT00264095: An Observational Study of Blood Management Techniques in Oncology Surgical Treatment
Official title: Blood Management Observation in Oncology Surgical Treatment (BOOST)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Blood Loss, Surgical
Neoplasms
Keywords: Anemia
Blood loss
Transfusion
Blood transfusion
Erythropoietin
Surgery
Surgical blood loss
Tumor
Cancer
Surgical resection
Tumor resection
Lead sponsor: Janssen-Cilag B.V.
Sponsor class: INDUSTRY
First posted: 2005-12-12
Enrollment: 488
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a malignant tumour for which surgery is the primary treatment and a minimal blood loss of 500 ml. and a maximum blood loss of 3000 ml. is expected.

Brief summary: The purpose of this study is to observe the methods used to manage blood loss in surgical procedures to remove tumors from patients with cancer and to determine if there is a relationship with the need for blood transfusions.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
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
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Frequency of use of different blood-saving techniques for the various types of operations performed from each of the centers participating in the study
timeFrame: within 24 hours after surgery
Other outcomes:
Locations:
city: Alkmaar
country: Netherlands
city: Amersfoort
country: Netherlands
city: Apeldoorn
country: Netherlands
city: Deventer
country: Netherlands
city: Dordrecht
country: Netherlands
city: Drachten
country: Netherlands
city: Nieuwegein
country: Netherlands
city: Nijmegen
country: Netherlands
city: Roosendaal
country: Netherlands
city: Sneek
country: Netherlands
city: Zwolle
country: Netherlands
Study officials:
affiliation: Janssen-Cilag B.V.
name: Janssen-Cilag B.V. Clinical Trial
role: STUDY_DIRECTOR
References: