Blood TransfusionPhase 2/3NCT05607940
Effect of Indication Based Blood Product Transfusion in Patients Undergoing Major Oncological Surgery
A Phase 2/3 study testing blood volume loss based blood transfusion and hemoglobin concentration based blood transfusion in people with Blood Transfusion, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
Investigators aimed to compare the effect on different indications (blood volume loss based VS hemoglobin concentration based ) based blood transfusion practices in patients undergoing major oncological surgery for pelvic or spinal tumor and investigate their postoperative complications. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Blood Transfusion
- What is being tested?
- blood volume loss based blood transfusion and hemoglobin concentration based blood transfusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Dec 2025
- Phase
- Phase 2/3
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 18 and 70
- patients with pelvic or spinal tumor
- conduct open resection surgery for tumor removal
- with expected surgery duration greater than 3 hours
- with expected blood loss greater than 400 ml
Who cannot join
- age < 18 or >70
- Limb tumor patients or patients with pelvic and spinal tumors undergoing closed internal fixation or vertebroplasty or minimally invasive surgery
- received chemotherapy or immunotherapy before surgery
- with expected surgery length less than 3 hours
- with expected intraoperative blood loss less than 400ml
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multi-center, Single Blinded Randomized Trial Investigating Indications Based Blood Transfusion Practices in Patients With Major Oncological Surgery
Investigators aimed to compare the effect on different indications (blood volume loss based VS hemoglobin concentration based ) based blood transfusion practices in patients undergoing major oncological surgery for pelvic or spinal tumor and investigate their postoperative complications.
Read the detailed description
260 patients underwent major oncological surgery for open pelvic or spinal tumor resection were included in this study. We looked at white blood cells, hemoglobin, hematocrit, neutrophil ratio, C-reactive protein, erythrocyte sedimentation rate, and IL-6 levels 1 day, 3 days, and 7 days after surgery The main question it sought to answer was whether there was a difference in postoperative complications 30 days after surgery between patients who received blood transfusions based on volume loss and those who received blood transfusions based on hemoglobin concentration during surgery.
- Conditions
- Blood Transfusion
- Being tested
- blood volume loss based blood transfusion, hemoglobin concentration based blood transfusion
- Keywords
- blood loss，transfusion，oncological surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood volume loss based blood transfusionProcedure or surgery
Blood transfusion is indicated based on the estimated intraoperative blood loss. When intraoperative blood loss exceeds 400ml, blood transfusion begin. At the end of the operation, we ensure that the volume of blood transfusion is no greater than the anticipated blood loss.
hemoglobin concentration based blood transfusionProcedure or surgery
Blood transfusion is indicated based on the intraoperative hemoglobin concentration. Intraoperative blood transfusion begins when hemoglobin concentration is blow 70g/L. Intraoperative blood transfusion stops when hemoglobin concentration reaches 80g/L
| Study group | Role | What they receive |
|---|---|---|
| blood volume loss based blood transfusion | Experimental | intraoperative blood transfusion begin once blood volume loss over 400ml Receives: Procedure: blood volume loss based blood transfusion |
| hemoglobin concentration based blood transfusion | Active comparator | intraoperative blood transfusion begin once hemoglobin concentration below 70g/L Receives: Procedure: hemoglobin concentration based blood transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of the postoperative complication
Major postoperative complications include but are not limited to surgical site infection, lung infection, deep vein thrombosis, pressure ulcers and so on
Measured: patients were carefully followed for complication occurrence 1 month after surgery.
Secondary outcomes (9)
transfusion of red packed blood cells
total volume of blood transfusion calculated after surgery
Measured: during hospitalization after surgery, an averagy of 1 week
length of hospital stay
Number of days patients stay in hospital after surgery.
Measured: during hospitalization after surgery, an averagy of 1 week
White blood cell count
White blood cell count was measured in patients 1 day, 3 days, and 7 days and 30 days after surgery.
Measured: 1 day，3 days，7 days，and 30 days after surgery
hemoglobin level
hemoglobin level was measured in patients 1 day, 3 days, and 7 days and 30 days after surgery.
Measured: 1 day，3 days，7 days，and 30 days after surgery
hematocrit
hematocrit was measured in patients 1 day, 3 days, and 7 days and 30 days after surgery.
Measured: 1 day，3 days，7 days，and 30 days after surgery
neutrophil ratio
the neutrophil ratio was measured in patients 1 day, 3 days, and 7 days and 30 days after surgery.
Measured: 1 day，3 days，7 days，and 30 days after surgery
C-reactive protein
C-reactive protein was measured in patients 1 day, 3 days, and 7 days and 30 days after surgery.
Measured: 1 day，3 days，7 days，and 30 days after surgery
erythrocyte sedimentation rate
erythrocyte sedimentation rate was measured in patients 1 day, 3 days, and 7 days and 30 days after surgery.
Measured: 1 day，3 days，7 days，and 30 days after surgery
nterleukin-6 level
Interleukin-6 level was measured in patients 1 day, 3 days, and 7 days and 30 days after surgery.
Measured: 1 day，3 days，7 days，and 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study startJan 2023 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood TransfusionStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaobo Yan, MD, Principal investigator, 2nd Affiliated Hospital Of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05607940
- Sponsor's protocol ID
- 2022_XB1028
- Status last verified
- Oct 2022
- First submitted
- 28 Oct 2022
- Last updated
- 7 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Single Blinded Randomized Trial Investigating Indications Based Blood Transfusion Practices in Patients With Major Oncological Surgery
- ClinicalTrials.gov ID
- NCT05607940
- Acronym / sponsor ID
- 2022_XB1028
- Conditions
- Blood Transfusion
- Keywords
- blood loss，transfusion，oncological surgery
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 7 Nov 2022 (actual)
- 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.
Investigators aimed to compare the effect on different indications (blood volume loss based VS hemoglobin concentration based ) based blood transfusion practices in patients undergoing major oncological surgery for pelvic or spinal tumor and investigate their postoperative complications.
Detailed description
260 patients underwent major oncological surgery for open pelvic or spinal tumor resection were included in this study. We looked at white blood cells, hemoglobin, hematocrit, neutrophil ratio, C-reactive protein, erythrocyte sedimentation rate, and IL-6 levels 1 day, 3 days, and 7 days after surgery The main question it sought to answer was whether there was a difference in postoperative complications 30 days after surgery between patients who received blood transfusions based on volume loss and those who received blood transfusions based on hemoglobin concentration during surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| blood volume loss based blood transfusion | Experimental | Procedure: blood volume loss based blood transfusionintraoperative blood transfusion begin once blood volume loss over 400ml |
| hemoglobin concentration based blood transfusion | Active comparator | Procedure: hemoglobin concentration based blood transfusionintraoperative blood transfusion begin once hemoglobin concentration below 70g/L |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age between 18 and 70
- patients with pelvic or spinal tumor
- conduct open resection surgery for tumor removal
- with expected surgery duration greater than 3 hours
- with expected blood loss greater than 400 ml
Key exclusion criteria (5 listed)
- age < 18 or >70
- Limb tumor patients or patients with pelvic and spinal tumors undergoing closed internal fixation or vertebroplasty or minimally invasive surgery
- received chemotherapy or immunotherapy before surgery
- with expected surgery length less than 3 hours
- with expected intraoperative blood loss less than 400ml
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 |
|---|---|---|
| blood volume loss based blood transfusionBlood transfusion is indicated based on the estimated intraoperative blood loss. When intraoperative blood loss exceeds 400ml, blood transfusion begin. At the end of the operation, we ensure that the volume of blood transfusion is no greater than the anticipated blood loss. | Procedure or surgery | blood volume loss based blood transfusion |
| hemoglobin concentration based blood transfusionBlood transfusion is indicated based on the intraoperative hemoglobin concentration. Intraoperative blood transfusion begins when hemoglobin concentration is blow 70g/L. Intraoperative blood transfusion stops when hemoglobin concentration reaches 80g/L | Procedure or surgery | hemoglobin concentration based blood transfusion |
Primary outcome
percentage of the postoperative complication
Time frame: patients were carefully followed for complication occurrence 1 month after surgery.
Major postoperative complications include but are not limited to surgical site infection, lung infection, deep vein thrombosis, pressure ulcers and so on
9 secondary outcomes
transfusion of red packed blood cells
Time frame: during hospitalization after surgery, an averagy of 1 week
length of hospital stay
Time frame: during hospitalization after surgery, an averagy of 1 week
White blood cell count
Time frame: 1 day，3 days，7 days，and 30 days after surgery
hemoglobin level
Time frame: 1 day，3 days，7 days，and 30 days after surgery
hematocrit
Time frame: 1 day，3 days，7 days，and 30 days after surgery
neutrophil ratio
Time frame: 1 day，3 days，7 days，and 30 days after surgery
C-reactive protein
Time frame: 1 day，3 days，7 days，and 30 days after surgery
erythrocyte sedimentation rate
Time frame: 1 day，3 days，7 days，and 30 days after surgery
nterleukin-6 level
Time frame: 1 day，3 days，7 days，and 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Individual participant dataSharing planned: No
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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.
Xiaobo Yan, MD principal investigator
2nd Affiliated Hospital Of Zhejiang University
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing blood volume loss based blood transfusion and hemoglobin concentration based blood transfusion in people with Blood Transfusion, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaobo Yan, MD (13588153306, yanxiaobo82@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of the postoperative complication (time frame: patients were carefully followed for complication occurrence 1 month 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 7 Nov 2022.