Red Blood Cells TransfusionPhase 3TRISOPNCT01502215
Transfusion Requirements in Surgical Oncologic Patient
A Phase 3 study testing Red blood cell transfusion in people with Red Blood Cells Transfusion and Oncologic Surgery, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Blood transfusion during perioperative period in patients undergoing to major surgery has been associated to several postoperative complications. Particularly in oncologic surgery, red blood cell transfusion has been investigated as a factor of worse outcome and cancer recurrence due to postoperative impairment of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Red Blood Cells Transfusion, Oncologic Surgery
- What is being tested?
- Red blood cell transfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2012to Dec 2012
- Phase
- Phase 3
- 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
Who may be able to join
- Patients with cancer after major abdominal surgery requiring post-operative ICU admission
- Adults patients
Who cannot join
- Age less than 18 year
- Hematologic Malignances
- Intensive care unit permanence lower than 24 hours
- Renal Chronic Failure in Renal Replacement Therapy
- Karnofsky Status < 50
- Previous anemia (hemoglobin lower than 9 g/dL)
Show all 11Show fewer
- Previous thrombocytopenia (platelet number lower than 50.000/mm3)
- Previous known coagulopathy
- Anticoagulation therapy
- Those unable to receive blood transfusion
- Patients who refused participation in the study
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto do Cancer do Estado de Sao Paulo
São Paulo, São Paulo, 01246000
About this study
Blood transfusion during perioperative period in patients undergoing to major surgery has been associated to several postoperative complications. Particularly in oncologic surgery, red blood cell transfusion has been investigated as a factor of worse outcome and cancer recurrence due to postoperative impairment of cellular immunity. Although red blood cell transfusion has decreased in worldwide clinical practice, this issue still remains a matter of controversy in oncologic surgery. There are no prospective studies comparing outcomes between restrictive or liberal of blood transfusion strategy in oncologic surgery. This study is a prospective and randomized study comparing clinical outcomes between two strategies of transfusion in oncologic surgery - liberal or restrictive
- Conditions
- Red Blood Cells Transfusion, Oncologic Surgery
- Being tested
- Red blood cell transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red blood cell transfusionOther
Red blood cell (RBC) transfusion will be given when hemoglobin fall below 9 g/dL since ICU admission until the discharge of intensive care unit. Following administration of the 1 RBC unit, a repeat hemoglobin levels is performed;if a patient's hemoglobin is 9 g/dL or higher, no additional transfusion is necessary.
Red blood cell transfusionOther
Red blood cell (RBC) transfusion will be only given when hemoglobin fall below 7 g/dL since ICU admission until the discharge of intensive care unit. Following administration of the 1 RBC unit, a repeat hematocrit is performed;if a patient's hemoglobin 7 g/dL or higher, no additional transfusion is necessary
| Study group | Role | What they receive |
|---|---|---|
| Liberal Transfusion Strategy | Active comparator | Liberal Group - transfusion when hemoglobin is lower than 9 g/dL. Intervention: Other: Red blood cell transfusion Receives: Other: Red blood cell transfusion |
| Restrictive Transfusion Strategy | Active comparator | Restrictive Group - transfusion when hemoglobin is lower than 7 g/dL Intervention: Other: Red blood cell transfusion Receives: Other: Red blood cell transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite end-point of mortality and severe complication
- The primary purpose of this study is to compare clinical outcomes after oncologic surgery in patients submitted to different strategies of red blood cell transfusion
Measured: 30 days
Secondary outcomes (1)
Hospital Length of Stay
- To compare length of stay in ICU, length of stay in Hospital, health-related quality of life and hospital costs.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionOct 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Red Blood Cells TransfusionStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juliano P Almeida, MD, Principal Investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01502215
- Sponsor's protocol ID
- 002/11
- Acronym
- TRISOP
- Status last verified
- Dec 2012
- First submitted
- 29 Dec 2011
- Last updated
- 5 Dec 2012
- Results posted
- No
Publications
Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.
PubMed 41114449Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.
PubMed 34932836
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transfusion Requirements in Surgical Oncologic Patient
- ClinicalTrials.gov ID
- NCT01502215
- Acronym / sponsor ID
- TRISOP / 002/11
- Conditions
- Red Blood Cells Transfusion, Oncologic Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 30 Dec 2011 (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.
Blood transfusion during perioperative period in patients undergoing to major surgery has been associated to several postoperative complications. Particularly in oncologic surgery, red blood cell transfusion has been investigated as a factor of worse outcome and cancer recurrence due to postoperative impairment of cellular immunity. Although red blood cell transfusion has decreased in worldwide clinical practice, this issue still remains a matter of controversy in oncologic surgery. There are no prospective studies comparing outcomes between restrictive or liberal of blood transfusion strategy in oncologic surgery. This study is a prospective and randomized study comparing clinical outcomes between two strategies of transfusion in oncologic surgery - liberal or restrictive
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liberal Transfusion Strategy | Active comparator | Other: Red blood cell transfusionLiberal Group - transfusion when hemoglobin is lower than 9 g/dL. Intervention: Other: Red blood cell transfusion |
| Restrictive Transfusion Strategy | Active comparator | Other: Red blood cell transfusionRestrictive Group - transfusion when hemoglobin is lower than 7 g/dL Intervention: Other: Red blood cell transfusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with cancer after major abdominal surgery requiring post-operative ICU admission
- Adults patients
Key exclusion criteria (11 listed)
- Age less than 18 year
- Hematologic Malignances
- Intensive care unit permanence lower than 24 hours
- Renal Chronic Failure in Renal Replacement Therapy
- Karnofsky Status < 50
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 |
|---|---|---|
| Red blood cell transfusionRed blood cell (RBC) transfusion will be given when hemoglobin fall below 9 g/dL since ICU admission until the discharge of intensive care unit. Following administration of the 1 RBC unit, a repeat hemoglobin levels is performed;if a patient's hemoglobin is 9 g/dL or higher, no additional transfusion is necessary. | Other | Liberal Transfusion Strategy |
| Red blood cell transfusionRed blood cell (RBC) transfusion will be only given when hemoglobin fall below 7 g/dL since ICU admission until the discharge of intensive care unit. Following administration of the 1 RBC unit, a repeat hematocrit is performed;if a patient's hemoglobin 7 g/dL or higher, no additional transfusion is necessary | Other | Restrictive Transfusion Strategy |
Primary outcome
Composite end-point of mortality and severe complication
Time frame: 30 days
• The primary purpose of this study is to compare clinical outcomes after oncologic surgery in patients submitted to different strategies of red blood cell transfusion
1 secondary outcome
Hospital Length of Stay
Time frame: 60 days
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 5 Dec 2012.
- Derived from this study: PubMed 41114449Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.
- Derived from this study: PubMed 34932836Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Red blood cell transfusion in people with Red Blood Cells Transfusion and Oncologic Surgery, run by University of Sao Paulo at 1 site in Brazil.
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 11 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 5 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Composite end-point of mortality and severe complication (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01502215, which also lists 2 linked publications.
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 5 Dec 2012.