An Observational Study of Blood Management Techniques in Oncology Surgical Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag B.V.
ClinicalTrials.gov Identifier:
NCT00264095
First received: December 9, 2005
Last updated: April 25, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Anemia
Blood Loss, Surgical
Neoplasms
Procedure: Oncological surgery
Phase 4

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Blood Management Observation in Oncology Surgical Treatment (BOOST)

Resource links provided by NLM:


Further study details as provided by Janssen-Cilag B.V.:

Primary Outcome Measures:
  • 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 [ Time Frame: 24 hours after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency of use of different blood-saving techniques for the various types of operations performed from each of the centers participating in the study [ Time Frame: within 24 hours after surgery ] [ Designated as safety issue: No ]

Enrollment: 488
Study Start Date: July 2004
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
001 Procedure: Oncological surgery
surgery is primary observed intervention and blood loss is between 500-3000 ml

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00264095

Locations
Netherlands
Alkmaar, Netherlands
Amersfoort, Netherlands
Apeldoorn, Netherlands
Deventer, Netherlands
Dordrecht, Netherlands
Drachten, Netherlands
Nieuwegein, Netherlands
Nijmegen, Netherlands
Roosendaal, Netherlands
Sneek, Netherlands
Zwolle, Netherlands
Sponsors and Collaborators
Janssen-Cilag B.V.
Investigators
Study Director: Janssen-Cilag B.V. Clinical Trial Janssen-Cilag B.V.
  More Information

No publications provided

Responsible Party: Janssen-Cilag B.V.
ClinicalTrials.gov Identifier: NCT00264095     History of Changes
Other Study ID Numbers: CR003460, EPOSUR4001
Study First Received: December 9, 2005
Last Updated: April 25, 2014
Health Authority: Netherlands: Netherlands Medicines Evaluation Board

Keywords provided by Janssen-Cilag B.V.:
Anemia
Blood loss
Transfusion
Blood transfusion
Erythropoietin
Surgery
Surgical blood loss
Tumor
Cancer
Surgical resection
Tumor resection

Additional relevant MeSH terms:
Anemia
Neoplasms
Hemorrhage
Blood Loss, Surgical
Hematologic Diseases
Pathologic Processes
Intraoperative Complications

ClinicalTrials.gov processed this record on July 20, 2014