An Observational Study of Blood Management Techniques in Oncology Surgical Treatment

Neoplasms Clinical Trial

Official title:

Blood Management Observation in Oncology Surgical Treatment (BOOST)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00264095
• Other study ID #: CR003460
• Secondary ID: EPOSUR4001
• Status: Completed
• Phase: Phase 4
• First received: December 9, 2005
• Last updated: April 25, 2014
• Start date: July 2004
• Est. completion date: February 2006

Study information

• Verified date: April 2014
• Source: Janssen-Cilag B.V.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Netherlands Medicines Evaluation Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 488
• Est. completion date: February 2006
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Anemia
• Blood Loss, Surgical
• Hemorrhage
• Neoplasms

Intervention

Procedure:
• Oncological surgery
surgery is primary observed intervention and blood loss is between 500-3000 ml

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag B.V.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		24 hours after surgery	No
Secondary	Frequency of use of different blood-saving techniques for the various types of operations performed from each of the centers participating in the study		within 24 hours after surgery	No