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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in China

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.

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 groups in NCT01597232
Study groupRoleWhat they receive
Transfusion trigger based on WCPTSExperimentalDetermination 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/dLActive comparatorThe 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 experienceActive comparatorDetermination 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.

  1. Proportion of patients received red-cell

    Proportion of patients received red-cell during peri-operative period

    Measured: Up to 30 days postoperatively

  2. 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)
  1. 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

  2. Intensive Care Unit (ICU) admission rate

    Proportion of patients with ICU admission

    Measured: Up to 30 days postoperatively

  3. 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

  4. 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

  5. Cost of transfusion and hospitalization

    Allogeneic blood cost and total in-hospital cost

    Measured: Up to 30 days postoperatively

  6. SF-8 questionnaire

    Follow-up of quality of life during one year after operation

    Measured: Up to one year postoperatively

  7. 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

  8. 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.

  1. First posted11 May 2012 (estimated)
  2. Study start7 May 2012
  3. Primary completion20 Jan 2017
  4. Study completion18 Feb 2019

Resources

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)
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

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.

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