Individualized Transfusion StrategyNCT04537000
Individualized Strategies of Red Blood Cell Transfusion for Perioperative Pediatric Patients
A study testing clinical condition score in people with Individualized Transfusion Strategy and Red Blood Cell, run by Children's Hospital of Fudan University.
Trial summary
The individualized strategies of red blood cell for perioperative pediatric patients are made based on the comparison between the clinical condition score and the Hb concentration. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Individualized Transfusion Strategy, Red Blood Cell, Perioperative Pediatric Patient
- What is being tested?
- clinical condition score
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2021to Sep 2022
- Phase
- Interventional
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- The Hb concentration is tested before operation. It is higher than 7g/dl and lower than 10g/dl. Or it is anticipated that it will decrease lower than 10g/dl.
Who cannot join
- The patient will not undergo an operation.
- newborn or premature baby
- patients accompanied with hemorrhagic disease or cyanotic heart disease
- patients with ischemic heart disease or ischemic cerebrovascular disease
About this study
The individualized strategies of red blood cell for perioperative pediatric patients are made based on the comparison between the clinical condition score and the Hb concentration.
Read the detailed description
The hypothesis is that the individual transfusion strategies will help to save blood resource, and meanwhile will not adversely affect the patients' clinical outcomes. Participants will be randomly divided into two groups, where the strategies of transfusion of red blood cell will be made following different principles. The strategies for patients in control group will be made by the attending doctors in charge according to the current Chinese red blood cell transfusion guidelines. For the patients in study group, the clinical condition will be identified every time red blood cell transfusion is considered. The strategies will be made according to the comparison between the score and the Hb concentration. The volume of the red blood cell used in these two groups will be compared. The number of patients who need transfusion in these two groups will be compared. The clinical outcomes will also be compared between the two groups.
- Conditions
- Individualized Transfusion Strategy, Red Blood Cell, Perioperative Pediatric Patient, Clinical Outcome
- Being tested
- clinical condition score
- Keywords
- transfusion, pediatric patient, individualized strategy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical condition scoreDiagnostic test
A score is firstly identified using a clinical condition scale including the concentration of inspired oxygen to maintain the percutaneous oxygen saturation (SPO2)≧95%, the fusion rate of catecholamine drugs to maintain normal blood pressure, the nasopharyngeal temperature and the oxygen saturation of central venous blood. The score was graded as 0, 1 and 2 points according to the patient's clinical condition. The score identified from the scale plus 7 finally makes the clinical condition score. If the score is higher than 10, it will be replaced with 10. That is to say, the highest clinical condition score is 10. If the clinical condition score≦Hb, blood red cell transfusion will not be started. If the clinical condition score>Hb, blood red cell transfusion will be started, and the volume will be calculated using the following formulation, transfusion volume(ml)=(clinical condition score - Hb)*body weight *5.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | The strategies of red blood cell transfusion for the pediatric patients in this group will be made by the attending doctors in charge based on the current transfusion guidelines. The attending doctors decide when to start blood red cell transfusion and order the volume of the blood red cell as the usual clinical practice. |
| study group | Experimental | For study group, the clinical condition score must be identified every time red blood cell transfusion is considered. The strategies of red blood cell transfusion for the pediatric patients in this group, including the trigger and the volume, will be made based on the comparison between the clinical condition score and the Hb concentration. Receives: Diagnostic Test: clinical condition score |
What is being measured
The primary outcome is the main question the study is designed to answer.
the volume of red blood cell (RBC) used adjusted to body weight
This is a repeated measurement data. The volume of RBC used adjusted to body weight = the volume of RBC (ml) used/ body weight(Kg). It is repeatedly recorded during this time frame. The data for intraoperation phase, for postoperation phase and for both intraoperation and postoperation phase are analyzed.The data would be measured at baseline (before operation), at the end of operation and on the 3rd days after operation.
Measured: baseline through 3 days after surgery
Secondary outcomes (10)
hemoglobin （Hb） concentration
Hb concentration is assessed by blood gas test. It is a repeated measurement data.
Measured: baseline through 3 days after surgery
heart rate
It is a repeated measurement data. It is recorded every 5-10 minutes during this time frame .
Measured: during operation(about 2-6 hours)
blood pressure（Systolic）
It is a repeated measurement data. It is (Systolic blood pressure ) recorded every 5-10 minutes during this time frame .
Measured: during operation (about 2-6 hours)
blood pressure（Diastolic）
It is a repeated measurement data. It is ( Diastolic blood pressure ) recorded every 5-10 minutes during this time frame .
Measured: during operation (about 2-6 hours)
lactate (Lac)
It is a repeated measurement data. It is recorded every time blood gas test is ordered during this time frame.
Measured: during operation (about 2-6 hours)
length of stay in post anesthesia care unit (PACU)
the time between the arrival of the patient to the PACU to the discharge to the ward
Measured: about 2-6 hours
infection
It is a binary variable. The data will be set as "1" if the patients got any infections such as wound infection, sepsis, etc. It will be set as "0" if there is no evidence for infection.
Measured: from the end of operation to the 3rd month after the operation.
unexpected transfer to intense care unit (ICU)
It is a binary variable. The data will be set as "1" if the patient is transferred to ICU unexpectedly. It will set as "0" if not.
Measured: from the end of operation to the 3rd day after the operation.
length of stay in hospital after operation
from the date of the operation to the date when the patient is discharged
Measured: from the date of operation to discharge （about 1-4 weeks ）
the number of patients who need RBC transfusion
This is a repeated measurement data. The number of patients who need RBC transfusion during operation and during the first 3 days after operation is recorded, respectively.
Measured: baseline through 3 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 posted3 Sep 2020
- Study startMay 2021 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionSep 2022 (estimated)
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Individualized Transfusion StrategyStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yun Shi, Master, Study chair, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04537000
- Sponsor's protocol ID
- transfusion-08-2020
- Status last verified
- Mar 2022
- First submitted
- 25 Aug 2020
- Last updated
- 8 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lavoie J. Blood transfusion risks and alternative strategies in pediatric patients. Paediatr Anaesth. 2011 Jan;21(1):14-24. doi: 10.1111/j.1460-9592.2010.03470.x.
PubMed 21155923Carson JL, Carless PA, Hebert PC. Transfusion thresholds and other strategies for guiding allogeneic red blood cell transfusion. Cochrane Database Syst Rev. 2012 Apr 18;4(4):CD002042. doi: 10.1002/14651858.CD002042.pub3.
PubMed 22513904AABB white papers: building a better patient blood management program identifying tools, soving problems and promoting patient safety; 2015
Carson JL, Guyatt G, Heddle NM, Grossman BJ, Cohn CS, Fung MK, Gernsheimer T, Holcomb JB, Kaplan LJ, Katz LM, Peterson N, Ramsey G, Rao SV, Roback JD, Shander A, Tobian AA. Clinical Practice Guidelines From the AABB: Red Blood Cell Transfusion Thresholds and Storage. JAMA. 2016 Nov 15;316(19):2025-2035. doi: 10.1001/jama.2016.9185.
PubMed 27732721Kozek-Langenecker SA, Ahmed AB, Afshari A, Albaladejo P, Aldecoa C, Barauskas G, De Robertis E, Faraoni D, Filipescu DC, Fries D, Haas T, Jacob M, Lance MD, Pitarch JVL, Mallett S, Meier J, Molnar ZL, Rahe-Meyer N, Samama CM, Stensballe J, Van der Linden PJF, Wikkelso AJ, Wouters P, Wyffels P, Zacharowski K. Management of severe perioperative bleeding: guidelines from the European Society of Anaesthesiology: First update 2016. Eur J Anaesthesiol. 2017 Jun;34(6):332-395. doi: 10.1097/EJA.0000000000000630.
PubMed 28459785Rouette J, Trottier H, Ducruet T, Beaunoyer M, Lacroix J, Tucci M; Canadian Critical Care Trials Group; PALISI Network. Red blood cell transfusion threshold in postsurgical pediatric intensive care patients: a randomized clinical trial. Ann Surg. 2010 Mar;251(3):421-7. doi: 10.1097/SLA.0b013e3181c5dc2e.
PubMed 20118780Zhang F, Zheng ZB, Zhu ZQ, Liu DX, Liu J. Application of Perioperative Transfusion Trigger Score in Patients Undergoing Surgical Treatment of Malignant Tumor. Indian J Hematol Blood Transfus. 2020 Jan;36(1):156-163. doi: 10.1007/s12288-019-01180-z. Epub 2019 Sep 12.
PubMed 32158099New HV, Grant-Casey J, Lowe D, Kelleher A, Hennem S, Stanworth SJ. Red blood cell transfusion practice in children: current status and areas for improvement? A study of the use of red blood cell transfusions in children and infants. Transfusion. 2014 Jan;54(1):119-27. doi: 10.1111/trf.12313. Epub 2013 Jun 30.
PubMed 23808415
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Strategies of Red Blood Cell Transfusion for Perioperative Pediatric Patients
- ClinicalTrials.gov ID
- NCT04537000
- Acronym / sponsor ID
- transfusion-08-2020
- Conditions
- Individualized Transfusion Strategy, Red Blood Cell, Perioperative Pediatric Patient, Clinical Outcome
- Keywords
- transfusion, pediatric patient, individualized strategy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- May 2021 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 3 Sep 2020 (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.
The individualized strategies of red blood cell for perioperative pediatric patients are made based on the comparison between the clinical condition score and the Hb concentration.
Detailed description
The hypothesis is that the individual transfusion strategies will help to save blood resource, and meanwhile will not adversely affect the patients' clinical outcomes. Participants will be randomly divided into two groups, where the strategies of transfusion of red blood cell will be made following different principles. The strategies for patients in control group will be made by the attending doctors in charge according to the current Chinese red blood cell transfusion guidelines. For the patients in study group, the clinical condition will be identified every time red blood cell transfusion is considered. The strategies will be made according to the comparison between the score and the Hb concentration. The volume of the red blood cell used in these two groups will be compared. The number of patients who need transfusion in these two groups will be compared. The clinical outcomes will also be compared between the two groups.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –The strategies of red blood cell transfusion for the pediatric patients in this group will be made by the attending doctors in charge based on the current transfusion guidelines. The attending doctors decide when to start blood red cell transfusion and order the volume of the blood red cell as the usual clinical practice. |
| study group | Experimental | Diagnostic Test: clinical condition scoreFor study group, the clinical condition score must be identified every time red blood cell transfusion is considered. The strategies of red blood cell transfusion for the pediatric patients in this group, including the trigger and the volume, will be made based on the comparison between the clinical condition score and the Hb concentration. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- The Hb concentration is tested before operation. It is higher than 7g/dl and lower than 10g/dl. Or it is anticipated that it will decrease lower than 10g/dl.
Key exclusion criteria (4 listed)
- The patient will not undergo an operation.
- newborn or premature baby
- patients accompanied with hemorrhagic disease or cyanotic heart disease
- patients with ischemic heart disease or ischemic cerebrovascular disease
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 |
|---|---|---|
| clinical condition scoreA score is firstly identified using a clinical condition scale including the concentration of inspired oxygen to maintain the percutaneous oxygen saturation (SPO2)≧95%, the fusion rate of catecholamine drugs to maintain normal blood pressure, the nasopharyngeal temperature and the oxygen saturation of central venous blood. The score was graded as 0, 1 and 2 points according to the patient's clinical condition. The score identified from the scale plus 7 finally makes the clinical condition score. If the score is higher than 10, it will be replaced with 10. That is to say, the highest clinical condition score is 10. If the clinical condition score≦Hb, blood red cell transfusion will not be started. If the clinical condition score>Hb, blood red cell transfusion will be started, and the volume will be calculated using the following formulation, transfusion volume(ml)=(clinical condition score - Hb)*body weight *5. | Diagnostic test | study group |
Primary outcome
the volume of red blood cell (RBC) used adjusted to body weight
Time frame: baseline through 3 days after surgery
This is a repeated measurement data. The volume of RBC used adjusted to body weight = the volume of RBC (ml) used/ body weight(Kg). It is repeatedly recorded during this time frame. The data for intraoperation phase, for postoperation phase and for both intraoperation and postoperation phase are analyzed.The data would be measured at baseline (before operation), at the end of operation and on the 3rd days after operation.
10 secondary outcomes
hemoglobin （Hb） concentration
Time frame: baseline through 3 days after surgery
heart rate
Time frame: during operation(about 2-6 hours)
blood pressure（Systolic）
Time frame: during operation (about 2-6 hours)
blood pressure（Diastolic）
Time frame: during operation (about 2-6 hours)
lactate (Lac)
Time frame: during operation (about 2-6 hours)
length of stay in post anesthesia care unit (PACU)
Time frame: about 2-6 hours
infection
Time frame: from the end of operation to the 3rd month after the operation.
unexpected transfer to intense care unit (ICU)
Time frame: from the end of operation to the 3rd day after the operation.
length of stay in hospital after operation
Time frame: from the date of operation to discharge （about 1-4 weeks ）
the number of patients who need RBC transfusion
Time frame: baseline through 3 days after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
- Background: PubMed 21155923Lavoie J. Blood transfusion risks and alternative strategies in pediatric patients. Paediatr Anaesth. 2011 Jan;21(1):14-24. doi: 10.1111/j.1460-9592.2010.03470.x.
- Background: PubMed 22513904Carson JL, Carless PA, Hebert PC. Transfusion thresholds and other strategies for guiding allogeneic red blood cell transfusion. Cochrane Database Syst Rev. 2012 Apr 18;4(4):CD002042. doi: 10.1002/14651858.CD002042.pub3.
- BackgroundAABB white papers: building a better patient blood management program identifying tools, soving problems and promoting patient safety; 2015
- Background: PubMed 27732721Carson JL, Guyatt G, Heddle NM, Grossman BJ, Cohn CS, Fung MK, Gernsheimer T, Holcomb JB, Kaplan LJ, Katz LM, Peterson N, Ramsey G, Rao SV, Roback JD, Shander A, Tobian AA. Clinical Practice Guidelines From the AABB: Red Blood Cell Transfusion Thresholds and Storage. JAMA. 2016 Nov 15;316(19):2025-2035. doi: 10.1001/jama.2016.9185.
- Background: PubMed 28459785Kozek-Langenecker SA, Ahmed AB, Afshari A, Albaladejo P, Aldecoa C, Barauskas G, De Robertis E, Faraoni D, Filipescu DC, Fries D, Haas T, Jacob M, Lance MD, Pitarch JVL, Mallett S, Meier J, Molnar ZL, Rahe-Meyer N, Samama CM, Stensballe J, Van der Linden PJF, Wikkelso AJ, Wouters P, Wyffels P, Zacharowski K. Management of severe perioperative bleeding: guidelines from the European Society of Anaesthesiology: First update 2016. Eur J Anaesthesiol. 2017 Jun;34(6):332-395. doi: 10.1097/EJA.0000000000000630.
- Background: PubMed 20118780Rouette J, Trottier H, Ducruet T, Beaunoyer M, Lacroix J, Tucci M; Canadian Critical Care Trials Group; PALISI Network. Red blood cell transfusion threshold in postsurgical pediatric intensive care patients: a randomized clinical trial. Ann Surg. 2010 Mar;251(3):421-7. doi: 10.1097/SLA.0b013e3181c5dc2e.
- Background: PubMed 32158099Zhang F, Zheng ZB, Zhu ZQ, Liu DX, Liu J. Application of Perioperative Transfusion Trigger Score in Patients Undergoing Surgical Treatment of Malignant Tumor. Indian J Hematol Blood Transfus. 2020 Jan;36(1):156-163. doi: 10.1007/s12288-019-01180-z. Epub 2019 Sep 12.
- Background: PubMed 23808415New HV, Grant-Casey J, Lowe D, Kelleher A, Hennem S, Stanworth SJ. Red blood cell transfusion practice in children: current status and areas for improvement? A study of the use of red blood cell transfusions in children and infants. Transfusion. 2014 Jan;54(1):119-27. doi: 10.1111/trf.12313. Epub 2013 Jun 30.
- 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.
Yun Shi, Master study chair
Children's Hospital of Fudan University
Questions about this trial
What is this clinical trial studying?
A study testing clinical condition score in people with Individualized Transfusion Strategy and Red Blood Cell, run by Children's Hospital of Fudan University.
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 1 inclusion and 4 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: withdrawn, as of the sponsor's last update on 8 Aug 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
the volume of red blood cell (RBC) used adjusted to body weight (time frame: baseline through 3 days after surgery). 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 NCT04537000, which also lists 8 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 8 Aug 2022.