AnemiaNCT00264095
An Observational Study of Blood Management Techniques in Oncology Surgical Treatment
An observational study of Anemia and Blood Loss, Surgical, run by Janssen-Cilag B.V. at 11 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Blood Loss, Surgical, Neoplasms
- What is being tested?
- Oncological surgery
- Type of treatment
- Surgery or procedure
- How many people
- 488 participants
- Where
- 11 sitesNetherlands
- Study dates
- Jul 2004to Feb 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Netherlands11 sites
Study site
Alkmaar
Study site
Amersfoort
Study site
Apeldoorn
Study site
Deventer
Study site
Dordrecht
Study site
Drachten
Study site
Nieuwegein
Study site
Nijmegen
Study site
Roosendaal
Study site
Sneek
Study site
Zwolle
About this study
Official title: Blood Management Observation in Oncology Surgical Treatment (BOOST)
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.
Read the 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.
- Conditions
- Anemia, Blood Loss, Surgical, Neoplasms
- Being tested
- Oncological surgery
- Keywords
- Anemia, Blood loss, Transfusion, Blood transfusion, Erythropoietin, Surgery, Surgical blood loss, Tumor, Cancer, Surgical resection, Tumor resection
- Medical subject headings
- Anemia, Blood Loss, Surgical, Neoplasms, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oncological surgeryProcedure or surgery
surgery is primary observed intervention and blood loss is between 500-3000 ml
| Study group | Role | What they receive |
|---|---|---|
| 001 | Not described Receives: Procedure: Oncological surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours after surgery
Secondary outcomes (1)
Frequency of use of different blood-saving techniques for the various types of operations performed from each of the centers participating in the study
Measured: within 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2005 (estimated)
- Study startJul 2004
- Primary completionFeb 2006
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 488 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag B.V. Clinical Trial, Study director, Janssen-Cilag B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00264095
- Sponsor's protocol ID
- CR003460
- Other IDs
- EPOSUR4001
- Status last verified
- Apr 2014
- First submitted
- 9 Dec 2005
- Last updated
- 28 Apr 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Management Observation in Oncology Surgical Treatment (BOOST)
- ClinicalTrials.gov ID
- NCT00264095
- Acronym / sponsor ID
- CR003460
- Conditions
- Anemia, Blood Loss, Surgical, Neoplasms
- Keywords
- Anemia, Blood loss, Transfusion, Blood transfusion, Erythropoietin, Surgery, Surgical blood loss, Tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 488 participants (actual)
- Lead sponsor
- Janssen-Cilag B.V.Industry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 12 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 001 | – | Procedure: Oncological surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oncological surgerysurgery is primary observed intervention and blood loss is between 500-3000 ml | Procedure or surgery | 001 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen-Cilag B.V. Clinical Trial study director
Janssen-Cilag B.V.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia and Blood Loss, Surgical, run by Janssen-Cilag B.V. at 11 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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 (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2014.