Transfusion Related ComplicationsWCPTSNCT01597232
Clinic Trial for West China Perioperative Transfusion Score (WCPTS)
A study testing Transfusion trigger based on WCPTS, Maintenance of hemoglobin level more than 10g/dL and Transfusion trigger based on experience in people with Transfusion Related Complications, run by West China Hospital at 1 site in China.
Trial summary
Guidelines for blood transfusion have been issued for years. According to these guidelines, red blood cells (RBCs) transfusion should be given when the hemoglobin level is less than 6g/dL or 7g/dL and is unnecessary when the level is more than 10g/dL. Read more about this study
- Who is it for?
- Ages 14 to 99 years
- Conditions the study is for
- Transfusion Related Complications
- What is being tested?
- Transfusion trigger based on WCPTS, Maintenance of hemoglobin level more than 10g/dL and Transfusion trigger based on experience
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,351 participants
- Where
- 1 siteChina
- Study dates
- 7 May 2012to 18 Feb 2019
- 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 14 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Height of usual place of residence less than 2,500 metres above sea level
- Perioperative hemoglobin level possibly less than 10g/dL
Who cannot join
- Emergency operation
- ASA classification V or VI
- Serious blood system diseases
- Dysfunction of hemoglobin
- Hypervolemic hemodilution
- Tumor metastasis
- Psychopathy
- Refuse to sign consent
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesiology, West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
About this study
Official title: Effect of West China Perioperative Transfusion Score (WCPTS) on Red Blood Cells Transfusion in Patients Undergoing Major Surgery: a Prospective, Multicenter, Randomized Controlled Trial
Guidelines for blood transfusion have been issued for years. According to these guidelines, red blood cells (RBCs) transfusion should be given when the hemoglobin level is less than 6g/dL or 7g/dL and is unnecessary when the level is more than 10g/dL. However, in all the guidelines, the determination of whether RBCs should be administered when the hemoglobin level is in the range of 6~10g/dL is based on the judgment from anesthesiologists or surgeons. Index of transfusion trigger for patients with hemoglobin level between 6g/dL and 10g/dL is necessary and important in clinical practice.
Based on the aim of blood transfusion that maintain the balance of oxygen supply and oxygen consumption, the investigators hypothesize that index of transfusion trigger for patients with hemoglobin level between 6g/dL and 10g/dL could be calculated by parameters including infusion rate of adrenalin for maintaining normal cardiac output, fraction of inspired oxygen, core temperature, and angina. To verify this hypothesis, the investigators present West China Perioperative Transfusion Score (WCPTS) for the trigger of transfusion according to the patient's history and monitoring parameters, and the investigators design a randomized controlled clinical trial to test this score.
Read the detailed description
Surgery and trauma are the most common reasons for major blood loss, and blood transfusion provide guarantee for massive hemorrhagic surgery, especially orthopedic, cardiac, liver, and gynecologic procedures. On the other hand, blood transfusion is associated with many risks including hemolytic and nonhemolytic reactions, transfusion related acute lung injury (TRALI), and others. Besides, blood is insufficient worldwide. How to eliminate allogeneic blood transfusion is an important part in clinical practice.
Guidelines for blood transfusion have been issued for years. According to these guidelines, red blood cells (RBCs) transfusion should be given when the hemoglobin level is less than 6g/dL or 7g/dL and is unnecessary when the level is more than 10g/dL. However, in all the guidelines, the determination of whether RBCs should be administered when the hemoglobin level is in the range of 6~10g/dL is based on the judgment from anesthesiologists or surgeons. Index of transfusion trigger for patients with hemoglobin level between 6g/dL and 10g/dL is necessary and important in clinical practice.
Based on the aim of blood transfusion that maintain the balance of oxygen supply and oxygen consumption, the investigators hypothesize that index of transfusion trigger for patients with hemoglobin level between 6g/dL and 10g/dL could be calculated by parameters including infusion rate of adrenalin for maintaining normal cardiac output, fraction of inspired oxygen for maintaining spO2≧95%, core temperature, and angina.
Peri-Operative Transfusion Trigger Score, POTTS The initial score is 6. If a patient's cardiac output is normal without infusion of adrenalin, his spO2 could be maintained more than 95% with FiO2≤35%, his core temperature is less than 38℃, and he has no angina, his score is 6.
If a patient has one or more problems, including his normal cardiac output should be maintained by infusion of adrenalin with its rate ≤0.05μg/kg.min, or his spO2 is maintained more than 95% with 36~50% FiO2, or his core temperature is between 38℃ to 40℃, or chest pain due to exercise,manual labor,or excitement, his score should be added 1 point for each problem.
If a patient has one or more problems, including his normal cardiac output should be maintained by infusion of adrenalin with its rate >0.06μg/kg.min, or his spO2 is maintained more than 95% with >51% FiO2, or his core temperature is >40℃, or sudden onset of chest pain at rest, his score should be added 2 point for each problem.
The initial POTTS score is 6, and the patient's score is calculated by the sum of each item.
Score 6:The transfusion trigger is 6g/dL, and the the patient's Hemoglobin level should be maintained not less than 6g/dL.
Score 7:The transfusion trigger is 7g/dL, and the the patient's Hemoglobin level should be maintained not less than 7g/dL.
Score 8:The transfusion trigger is 8g/dL, and the the patient's Hemoglobin level should be maintained not less than 8g/dL.
Score 9:The transfusion trigger is 9g/dL, and the the patient's Hemoglobin level should be maintained not less than 9g/dL.
Score 10 or >10:The transfusion trigger is 10g/dL, and the the patient's Hemoglobin level should be maintained not less than 10g/dL.
For example, if a patient need ≤0.05μg/kg.min adrenalin to maintain his normal cardiac output (+1), his spO2 could be maintained more than 95% with FiO2≤35%, his core temperature is less than 38℃, and he has sudden onset of chest pain at rest (+2), his POTTS score could be calculated as 6 +1 (≤0.05μg/kg.min adrenalin to maintain his normal cardiac output) +2 (sudden onset of chest pain at rest), and his POTTS score is 9. That means this patient's transfusion trigger is 9g/dL, and his hemoglobin level should be maintained above 9 at this situation.
- Conditions
- Transfusion Related Complications
- Being tested
- Transfusion trigger based on WCPTS, Maintenance of hemoglobin level more than 10g/dL, Transfusion trigger based on experience
- Keywords
- Transfusion trigger, Hemoglobin level
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transfusion trigger based on WCPTSOther
Determination of whether a patient needs red blood cell transfusion or which hemoglobin level should be maintained is based on WCPTS
Maintenance of hemoglobin level more than 10g/dLOther
The patient's hemoglobin level is maintained more than 10g/dL perioperatively
Transfusion trigger based on experienceOther
Determination of whether the patient need red blood cell transfusion or which hemoglobin level should be maintained is based on the physician's experience
| Study group | Role | What they receive |
|---|---|---|
| Transfusion trigger based on WCPTS | Experimental | Determination of whether a patient need red blood cells transfusion or which hemoglobin level should be maintained is based on WCPTS. Receives: Other: Transfusion trigger based on WCPTS |
| Hemoglobin level 10g/dL | Active comparator | The patient's hemoglobin level is maintained more than 10g/dL perioperatively. Receives: Other: Maintenance of hemoglobin level more than 10g/dL |
| Transfusion trigger based on experience | Active comparator | Determination of whether a patient need red blood cell transfusion or which hemoglobin level should be maintained is base on the physician's experience. Receives: Other: Transfusion trigger based on experience |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients received red-cell
Proportion of patients received red-cell during peri-operative period
Measured: Up to 30 days postoperatively
Composite of in-hospital complications and all-cause mortality by day-30
Composite of in-hospital complications and all-cause mortality by day-30, and complications were defined as the serious ones that cause prolonged hospitalization, or life threatening, but could get recovery after intense treatment during hospitalization, or life threatening, resulting in significantly decreased quality of life.
Measured: Up to 30 days postoperatively
Secondary outcomes (8)
Incidences of in-hospital infectious complications.
Infectious complications were defined as infection at any site, such as pulmonary infection, urinary infection, etc.
Measured: Up to 30 days postoperatively
Intensive Care Unit (ICU) admission rate
Proportion of patients with ICU admission
Measured: Up to 30 days postoperatively
Length of hospital stay (LOS)
LOS was defined as the time frame from the day of hospital admission to discharge from the hospital (unit: days).
Measured: Up to 30 days postoperatively
Hemoglobin level at different time points
Hb level was measured at the time points as follows: before operation, completion of operation, 24hrs after operation, before discharge, and before all red cells transfusion
Measured: Up to 30 days postoperatively
Cost of transfusion and hospitalization
Allogeneic blood cost and total in-hospital cost
Measured: Up to 30 days postoperatively
SF-8 questionnaire
Follow-up of quality of life during one year after operation
Measured: Up to one year postoperatively
Healing status of surgical incision
Healing status of surgical incision was divided into grade Ⅰ, Ⅱ, and Ⅲ. Grade Ⅰ was defined as the wound healing nicely without any adverse reaction, grade Ⅱ was defined as the inflammatory wound without the need of re-incision, and grade Ⅲ was defined as the wound suppurated with the need of re-incision for clearance.
Measured: Up to 30 days postoperatively
All-cause mortality during 1-year after operation
All-cause mortality by day-60, day-180 and 1-year after operation
Measured: Up to one year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2012 (estimated)
- Study start7 May 2012
- Primary completion20 Jan 2017
- Study completion18 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transfusion Related ComplicationsStudies of the same condition, open and under way.
- More trials run by West China HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,351 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ren Liao, West China Hospital
- Investigators
- Ren Liao, M.D., Study director, Department of Anesthesiology, West China Hospital, Sichuan UniversityJin Liu, M.D., Principal investigator, Department of Anesthesiology, West China Hospital, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01597232
- Sponsor's protocol ID
- WCPTS120508
- Acronym
- WCPTS
- Status last verified
- Nov 2019
- First submitted
- 9 May 2012
- Last updated
- 20 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Liao R, Liu J, Zhang W, Zheng H, Zhu Z, Sun H, Yu Z, Jia H, Sun Y, Qin L, Yu W, Luo Z, Chen Y, Zhang K, Ma L, Yang H, Wu H, Liu L, Yuan F, Xu H, Zhang J, Zhang L, Liu D, Huang H. Individualized red-cell transfusion strategy for non-cardiac surgery in adults: a randomized controlled trial. Chin Med J (Engl). 2023 Dec 5;136(23):2857-2866. doi: 10.1097/CM9.0000000000002584.
PubMed 37052133
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of West China Perioperative Transfusion Score (WCPTS) on Red Blood Cells Transfusion in Patients Undergoing Major Surgery: a Prospective, Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01597232
- Acronym / sponsor ID
- WCPTS / WCPTS120508
- Conditions
- Transfusion Related Complications
- Keywords
- Transfusion trigger, Hemoglobin level
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,351 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 7 May 2012 (actual)
- Primary completion
- 20 Jan 2017 (actual)
- Study completion
- 18 Feb 2019 (actual)
- First posted
- 11 May 2012 (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.
Guidelines for blood transfusion have been issued for years. According to these guidelines, red blood cells (RBCs) transfusion should be given when the hemoglobin level is less than 6g/dL or 7g/dL and is unnecessary when the level is more than 10g/dL. However, in all the guidelines, the determination of whether RBCs should be administered when the hemoglobin level is in the range of 6~10g/dL is based on the judgment from anesthesiologists or surgeons. Index of transfusion trigger for patients with hemoglobin level between 6g/dL and 10g/dL is necessary and important in clinical practice.
Based on the aim of blood transfusion that maintain the balance of oxygen supply and oxygen consumption, the investigators hypothesize that index of transfusion trigger for patients with hemoglobin level between 6g/dL and 10g/dL could be calculated by parameters including infusion rate of adrenalin for maintaining normal cardiac output, fraction of inspired oxygen, core temperature, and angina. To verify this hypothesis, the investigators present West China Perioperative Transfusion Score (WCPTS) for the trigger of transfusion according to the patient's history and monitoring parameters, and the investigators design a randomized controlled clinical trial to test this score.
Detailed description
Surgery and trauma are the most common reasons for major blood loss, and blood transfusion provide guarantee for massive hemorrhagic surgery, especially orthopedic, cardiac, liver, and gynecologic procedures. On the other hand, blood transfusion is associated with many risks including hemolytic and nonhemolytic reactions, transfusion related acute lung injury (TRALI), and others. Besides, blood is insufficient worldwide. How to eliminate allogeneic blood transfusion is an important part in clinical practice.
Guidelines for blood transfusion have been issued for years. According to these guidelines, red blood cells (RBCs) transfusion should be given when the hemoglobin level is less than 6g/dL or 7g/dL and is unnecessary when the level is more than 10g/dL. However, in all the guidelines, the determination of whether RBCs should be administered when the hemoglobin level is in the range of 6~10g/dL is based on the judgment from anesthesiologists or surgeons. Index of transfusion trigger for patients with hemoglobin level between 6g/dL and 10g/dL is necessary and important in clinical practice.
Based on the aim of blood transfusion that maintain the balance of oxygen supply and oxygen consumption, the investigators hypothesize that index of transfusion trigger for patients with hemoglobin level between 6g/dL and 10g/dL could be calculated by parameters including infusion rate of adrenalin for maintaining normal cardiac output, fraction of inspired oxygen for maintaining spO2≧95%, core temperature, and angina.
Peri-Operative Transfusion Trigger Score, POTTS The initial score is 6. If a patient's cardiac output is normal without infusion of adrenalin, his spO2 could be maintained more than 95% with FiO2≤35%, his core temperature is less than 38℃, and he has no angina, his score is 6.
If a patient has one or more problems, including his normal cardiac output should be maintained by infusion of adrenalin with its rate ≤0.05μg/kg.min, or his spO2 is maintained more than 95% with 36~50% FiO2, or his core temperature is between 38℃ to 40℃, or chest pain due to exercise,manual labor,or excitement, his score should be added 1 point for each problem.
If a patient has one or more problems, including his normal cardiac output should be maintained by infusion of adrenalin with its rate >0.06μg/kg.min, or his spO2 is maintained more than 95% with >51% FiO2, or his core temperature is >40℃, or sudden onset of chest pain at rest, his score should be added 2 point for each problem.
The initial POTTS score is 6, and the patient's score is calculated by the sum of each item.
Score 6:The transfusion trigger is 6g/dL, and the the patient's Hemoglobin level should be maintained not less than 6g/dL.
Score 7:The transfusion trigger is 7g/dL, and the the patient's Hemoglobin level should be maintained not less than 7g/dL.
Score 8:The transfusion trigger is 8g/dL, and the the patient's Hemoglobin level should be maintained not less than 8g/dL.
Score 9:The transfusion trigger is 9g/dL, and the the patient's Hemoglobin level should be maintained not less than 9g/dL.
Score 10 or >10:The transfusion trigger is 10g/dL, and the the patient's Hemoglobin level should be maintained not less than 10g/dL.
For example, if a patient need ≤0.05μg/kg.min adrenalin to maintain his normal cardiac output (+1), his spO2 could be maintained more than 95% with FiO2≤35%, his core temperature is less than 38℃, and he has sudden onset of chest pain at rest (+2), his POTTS score could be calculated as 6 +1 (≤0.05μg/kg.min adrenalin to maintain his normal cardiac output) +2 (sudden onset of chest pain at rest), and his POTTS score is 9. That means this patient's transfusion trigger is 9g/dL, and his hemoglobin level should be maintained above 9 at this situation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transfusion trigger based on WCPTS | Experimental | Other: Transfusion trigger based on WCPTSDetermination of whether a patient need red blood cells transfusion or which hemoglobin level should be maintained is based on WCPTS. |
| Hemoglobin level 10g/dL | Active comparator | Other: Maintenance of hemoglobin level more than 10g/dLThe patient's hemoglobin level is maintained more than 10g/dL perioperatively. |
| Transfusion trigger based on experience | Active comparator | Other: Transfusion trigger based on experienceDetermination of whether a patient need red blood cell transfusion or which hemoglobin level should be maintained is base on the physician's experience. |
Who may qualify
- Ages
- 14 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Height of usual place of residence less than 2,500 metres above sea level
- Perioperative hemoglobin level possibly less than 10g/dL
Key exclusion criteria (8 listed)
- Emergency operation
- ASA classification V or VI
- Serious blood system diseases
- Dysfunction of hemoglobin
- Hypervolemic hemodilution
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 |
|---|---|---|
| Transfusion trigger based on WCPTSDetermination of whether a patient needs red blood cell transfusion or which hemoglobin level should be maintained is based on WCPTS | Other | Transfusion trigger based on WCPTS |
| Maintenance of hemoglobin level more than 10g/dLThe patient's hemoglobin level is maintained more than 10g/dL perioperatively | Other | Hemoglobin level 10g/dL |
| Transfusion trigger based on experienceDetermination of whether the patient need red blood cell transfusion or which hemoglobin level should be maintained is based on the physician's experience | Other | Transfusion trigger based on experience |
Primary outcome
Proportion of patients received red-cell
Time frame: Up to 30 days postoperatively
Proportion of patients received red-cell during peri-operative period
Composite of in-hospital complications and all-cause mortality by day-30
Time frame: Up to 30 days postoperatively
Composite of in-hospital complications and all-cause mortality by day-30, and complications were defined as the serious ones that cause prolonged hospitalization, or life threatening, but could get recovery after intense treatment during hospitalization, or life threatening, resulting in significantly decreased quality of life.
8 secondary outcomes
Incidences of in-hospital infectious complications.
Time frame: Up to 30 days postoperatively
Intensive Care Unit (ICU) admission rate
Time frame: Up to 30 days postoperatively
Length of hospital stay (LOS)
Time frame: Up to 30 days postoperatively
Hemoglobin level at different time points
Time frame: Up to 30 days postoperatively
Cost of transfusion and hospitalization
Time frame: Up to 30 days postoperatively
SF-8 questionnaire
Time frame: Up to one year postoperatively
Healing status of surgical incision
Time frame: Up to 30 days postoperatively
All-cause mortality during 1-year after operation
Time frame: Up to one year postoperatively
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 20 Nov 2019.
- Derived from this study: PubMed 37052133Liao R, Liu J, Zhang W, Zheng H, Zhu Z, Sun H, Yu Z, Jia H, Sun Y, Qin L, Yu W, Luo Z, Chen Y, Zhang K, Ma L, Yang H, Wu H, Liu L, Yuan F, Xu H, Zhang J, Zhang L, Liu D, Huang H. Individualized red-cell transfusion strategy for non-cardiac surgery in adults: a randomized controlled trial. Chin Med J (Engl). 2023 Dec 5;136(23):2857-2866. doi: 10.1097/CM9.0000000000002584.
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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.
Ren Liao, M.D. study director
Department of Anesthesiology, West China Hospital, Sichuan University
Jin Liu, M.D. principal investigator
Department of Anesthesiology, West China Hospital, Sichuan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transfusion trigger based on WCPTS, Maintenance of hemoglobin level more than 10g/dL and Transfusion trigger based on experience in people with Transfusion Related Complications, run by West China Hospital at 1 site in China.
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 8 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 20 Nov 2019. 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 China. 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?
Proportion of patients received red-cell (time frame: Up to 30 days postoperatively). The study lists 2 primary outcomes in all. 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 NCT01597232, which also lists 1 linked publication.
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 20 Nov 2019.