Transfusion Related ComplicationsWCPTSNCT01345643
Clinical Trial of West-China Perioperative Transfusion Score (WCPTS）for Massive Hemorrhagic Surgery
A study testing Maintenance of hemoglobin level not less than 10g/dL and Transfusion trigger based on WCPTS in people with Transfusion Related Complications, run by Ren Liao 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 15 to 70 years
- Conditions the study is for
- Transfusion Related Complications
- What is being tested?
- Maintenance of hemoglobin level not less than 10g/dL and Transfusion trigger based on WCPTS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteChina
- Study dates
- Feb 2011to Feb 2014
- 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 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients aged 15years to 70years.
- American Society of Anesthesiologists (ASA) physical status I, II, Ⅲ or Ⅳ.
- Undergoing elective spine surgery with estimated blood loss more than 800ml or 20% of the patient's whole blood volume.
- Glasgow Coma Scale (GCS) score of 15.
- Ability to communicate by telephone call.
- Informed consent has been signed by the patient or his legal guardian.
Who cannot join
- Declined to receive blood transfusion.
- Refuse to sign consent.
- Pregnancy.
- Psychopathy.
- Coagulopathy.
- Impairment of communication or cognition.
- Active participation in another trial where the primary endpoint follow-up is ongoing.
- Unwillingness or inability to comply with protocol procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Clinical Trial of Transfusion Under the Guidance of West-China Perioperative Transfusion Score(WCPTS）for Massive Hemorrhagic Surgery
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 7~10g/dL is based on the judgment from anesthesiologists or surgeons. Index of transfusion trigger for patients with hemoglobin level between 7/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 7/dL and 10g/dL could be calculated by their history about heart and blood pressure, and routine monitoring parameters including pulse oximetry, temperature, and the use of vasoactive medications. 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, 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 by many health institutions or organizations in different countries. 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 7~10g/dL is based on the judgment from anesthesiologists or surgeons on the patient's condition including intravascular volume status, ongoing bleeding, any risk factors for vital organs ischemia or hypoxia, and so on. Index of transfusion trigger for patients with hemoglobin level between 7/dL and 10g/dL is necessary and important in clinical practice.
The aim of blood transfusion is to provide sufficient oxygen for the whole body, and to maintain the balance of oxygen supply and oxygen consumption. Factors associated with oxygen supply are hemoglobin level, cardiac output (CO), and oxygen saturation. Oxygen consumption is increased by the increase of metabolism, which could be reflected by increase of heart rate, blood pressure, and body temperature. If a patient's oxygen supply is decreased or oxygen consumption is increased, he will need a higher hemoglobin level to maintain the balance. Based on these findings, the investigators hypothesize that index of transfusion trigger for patients with hemoglobin level between 7/dL and 10g/dL could be calculated by their CO (reflected by the use of adrenalin), and routine monitoring parameters including pulse oximetry and core temperature.
West China Perioperative Transfusion Score (WCPTS)
The initial score is 7.
If a patient's cardiac output (CO) is normal without continuous infusion of adrenalin, or his SpO2 is more than 95%, or his core temperature is less than 38℃, he doesn't have any bonus point factor, and his score is 7.
If a patient's CO is maintained in normal range by continuous adrenalin infusion with concentration of less than 0.05μg/kg.min, or his SpO2 is 85~94%, or his core temperature is 38~40℃, his score should be added 1 point for every item mentioned above.
If a patient's CO is only maintained by continuous adrenalin infusion with concentration of more than 0.05μg/kg.min, or his SpO2 is less than 84%, or his core temperature is above 40℃, his score should be added 2 points for every item mentioned above.
For example, if a patient's CO is normal, his SpO2 is more than 95%, and his core temperature is 39℃,his WCPTS should be calcultaed as 7 plus 1 (core temperature is 39℃), and his final score is 8.
Here's another example, if a patient's CO is normal, his core temperature is less than 38℃, but he has COPD and his SpO2 is less than 84%, his score could be calculated as 7 plus 2(SpO2 is less than 84%), and his final score is 9.
Value of SaO2 is evaluated 5min after endotracheal intubation with inhalation of compressive air.
The initial score is 7，and the patient's score is calculated by 7 plus the sum of every item.
Score 7：To maintain the patient's Hb level not less than 7g/dL
Score 8：To maintain the patient's Hb level not less than 8g/dL
Score 9：To maintain the patient's Hb level not less than 9g/dL
Score 10 or >10：To maintain the patient's Hb level not less than 10g/dL
- Conditions
- Transfusion Related Complications
- Being tested
- Maintenance of hemoglobin level not less than 10g/dL, Transfusion trigger based on WCPTS
- Keywords
- Transfusion, Hemoglobin level
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maintenance of hemoglobin level not less than 10g/dLOther
The patient's hemoglobin level is maintained not less than 10g/dL perioperatively.
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
| Study group | Role | What they receive |
|---|---|---|
| Hemoglobin level based on WCPTS | Experimental | According to WCPTS, the patient's hemoglobin level will be maintained not less than 7,8,9,or 10g/dL. Determination of whether a patient need red blood cells transfusion is based on WCPT Score. Receives: Other: Transfusion trigger based on WCPTS |
| Hemoglobin level 10g/dL | Active comparator | The patient's hemoglobin level is maintained not less than 10g/dL perioperatively. Receives: Other: Maintenance of hemoglobin level not less than 10g/dL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who received red blood cells transfusion
Proportion of patients who received red blood cells transfusion (Patients received red cells transfusion/ total number of the patients)
Measured: Up to 12 weeks.
Transfusion volume of red blood cells
Volume of red blood cells transfused to the patients (units)
Measured: Up to 12 weeks.
Secondary outcomes (8)
All-cause mortality in 30 days post-operatively
Death for any reason within 30 days post-operatively
Measured: Up to 30 days post-operatively.
In-hospital complications
In-hospital complications include: (1) Cardiac and pulmonary events such as cardiac arrest, arrhythmia, heart failure, pulmonary edema, etc. (2) Febrility without antibiotic treatment. (3) Infection needed antibiotic treatment. (4) Re-operation for bleeding. (5) Deep venous thrombosis. (6) Other complications.
Measured: Up to 12 weeks.
Hb level at different time points
Hb level at admission, 1 day before surgery, during operation, 1,2,3 days after surgery, before discharge
Measured: Up to 12 weeks.
Length of ICU stay and hospitalization
From admission to ICU to discharge from ICU
Measured: Up to 12 weeks.
Costs of hospitalization and transfusion
All the medical costs.
Measured: Up to 12 weeks.
Stitches removal time
The time period (days) from the day of operation to the day of stitches removal
Measured: Up to six months postoperatively
Healing status of surgical incision
Healing status is 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 six months postoperatively
Time to get recovery of daily life and/or working
Tthe time period (weeks) from the day of discharge to the day that patient get recovery of normal daily life and/or working during a six-month follow-up.
Measured: Up to six months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2011 (estimated)
- Study startFeb 2011
- Primary completionJun 2012
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transfusion Related ComplicationsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ren Liao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ren Liao, West China Hospital
- Investigators
- Ren Liao, M.D., Study director, Department of Anesthesiology, West China Hospital, Sichuan UniversityJin Liu, M.D., Study chair, Department of Anesthesiology, West China Hospital, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01345643
- Sponsor's protocol ID
- WCPTS110419
- Acronym
- WCPTS
- Status last verified
- May 2024
- First submitted
- 26 Apr 2011
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial of Transfusion Under the Guidance of West-China Perioperative Transfusion Score(WCPTS）for Massive Hemorrhagic Surgery
- ClinicalTrials.gov ID
- NCT01345643
- Acronym / sponsor ID
- WCPTS / WCPTS110419
- Conditions
- Transfusion Related Complications
- Keywords
- Transfusion, Hemoglobin level
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Ren LiaoUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 2 May 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.
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 7~10g/dL is based on the judgment from anesthesiologists or surgeons. Index of transfusion trigger for patients with hemoglobin level between 7/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 7/dL and 10g/dL could be calculated by their history about heart and blood pressure, and routine monitoring parameters including pulse oximetry, temperature, and the use of vasoactive medications. 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, 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 by many health institutions or organizations in different countries. 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 7~10g/dL is based on the judgment from anesthesiologists or surgeons on the patient's condition including intravascular volume status, ongoing bleeding, any risk factors for vital organs ischemia or hypoxia, and so on. Index of transfusion trigger for patients with hemoglobin level between 7/dL and 10g/dL is necessary and important in clinical practice.
The aim of blood transfusion is to provide sufficient oxygen for the whole body, and to maintain the balance of oxygen supply and oxygen consumption. Factors associated with oxygen supply are hemoglobin level, cardiac output (CO), and oxygen saturation. Oxygen consumption is increased by the increase of metabolism, which could be reflected by increase of heart rate, blood pressure, and body temperature. If a patient's oxygen supply is decreased or oxygen consumption is increased, he will need a higher hemoglobin level to maintain the balance. Based on these findings, the investigators hypothesize that index of transfusion trigger for patients with hemoglobin level between 7/dL and 10g/dL could be calculated by their CO (reflected by the use of adrenalin), and routine monitoring parameters including pulse oximetry and core temperature.
West China Perioperative Transfusion Score (WCPTS)
The initial score is 7.
If a patient's cardiac output (CO) is normal without continuous infusion of adrenalin, or his SpO2 is more than 95%, or his core temperature is less than 38℃, he doesn't have any bonus point factor, and his score is 7.
If a patient's CO is maintained in normal range by continuous adrenalin infusion with concentration of less than 0.05μg/kg.min, or his SpO2 is 85~94%, or his core temperature is 38~40℃, his score should be added 1 point for every item mentioned above.
If a patient's CO is only maintained by continuous adrenalin infusion with concentration of more than 0.05μg/kg.min, or his SpO2 is less than 84%, or his core temperature is above 40℃, his score should be added 2 points for every item mentioned above.
For example, if a patient's CO is normal, his SpO2 is more than 95%, and his core temperature is 39℃,his WCPTS should be calcultaed as 7 plus 1 (core temperature is 39℃), and his final score is 8.
Here's another example, if a patient's CO is normal, his core temperature is less than 38℃, but he has COPD and his SpO2 is less than 84%, his score could be calculated as 7 plus 2(SpO2 is less than 84%), and his final score is 9.
Value of SaO2 is evaluated 5min after endotracheal intubation with inhalation of compressive air.
The initial score is 7，and the patient's score is calculated by 7 plus the sum of every item.
Score 7：To maintain the patient's Hb level not less than 7g/dL
Score 8：To maintain the patient's Hb level not less than 8g/dL
Score 9：To maintain the patient's Hb level not less than 9g/dL
Score 10 or >10：To maintain the patient's Hb level not less than 10g/dL
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemoglobin level based on WCPTS | Experimental | Other: Transfusion trigger based on WCPTSAccording to WCPTS, the patient's hemoglobin level will be maintained not less than 7,8,9,or 10g/dL. Determination of whether a patient need red blood cells transfusion is based on WCPT Score. |
| Hemoglobin level 10g/dL | Active comparator | Other: Maintenance of hemoglobin level not less than 10g/dLThe patient's hemoglobin level is maintained not less than 10g/dL perioperatively. |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged 15years to 70years.
- American Society of Anesthesiologists (ASA) physical status I, II, Ⅲ or Ⅳ.
- Undergoing elective spine surgery with estimated blood loss more than 800ml or 20% of the patient's whole blood volume.
- Glasgow Coma Scale (GCS) score of 15.
- Ability to communicate by telephone call.
Key exclusion criteria (8 listed)
- Declined to receive blood transfusion.
- Refuse to sign consent.
- Pregnancy.
- Psychopathy.
- Coagulopathy.
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 |
|---|---|---|
| Maintenance of hemoglobin level not less than 10g/dLThe patient's hemoglobin level is maintained not less than 10g/dL perioperatively. | Other | Hemoglobin level 10g/dL |
| 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 | Hemoglobin level based on WCPTS |
Primary outcome
Proportion of patients who received red blood cells transfusion
Time frame: Up to 12 weeks.
Proportion of patients who received red blood cells transfusion (Patients received red cells transfusion/ total number of the patients)
Transfusion volume of red blood cells
Time frame: Up to 12 weeks.
Volume of red blood cells transfused to the patients (units)
8 secondary outcomes
All-cause mortality in 30 days post-operatively
Time frame: Up to 30 days post-operatively.
In-hospital complications
Time frame: Up to 12 weeks.
Hb level at different time points
Time frame: Up to 12 weeks.
Length of ICU stay and hospitalization
Time frame: Up to 12 weeks.
Costs of hospitalization and transfusion
Time frame: Up to 12 weeks.
Stitches removal time
Time frame: Up to six months postoperatively
Healing status of surgical incision
Time frame: Up to six months postoperatively
Time to get recovery of daily life and/or working
Time frame: Up to six months 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 7 May 2024.
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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. study chair
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 Maintenance of hemoglobin level not less than 10g/dL and Transfusion trigger based on WCPTS in people with Transfusion Related Complications, run by Ren Liao 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 6 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 7 May 2024. 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 who received red blood cells transfusion (time frame: Up to 12 weeks.). 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?
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 May 2024.