Clinic Trial for West China Perioperative Transfusion Score (WCPTS)

NCT01597232 | Completed DMC

• 1 other identifier: WCPTS120508
• Study Type: interventional
• Target: 1,351
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Transfusion Related Complications

Keywords

Transfusion trigger; Hemoglobin level

Outcome Measures

Primary Outcomes (2)

• Proportion of patients received red-cell

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

  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.

  Up to 30 days postoperatively

Secondary Outcomes (8)

• Incidences of in-hospital infectious complications.

  Up to 30 days postoperatively

• Intensive Care Unit (ICU) admission rate

  Up to 30 days postoperatively

• Length of hospital stay (LOS)

  Up to 30 days postoperatively

• Hemoglobin level at different time points

  Up to 30 days postoperatively

• Cost of transfusion and hospitalization

  Up to 30 days postoperatively

Study Arms (3)

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.

Other: Transfusion trigger based on WCPTS

Hemoglobin level 10g/dL

ACTIVE COMPARATOR

The patient's hemoglobin level is maintained more than 10g/dL perioperatively.

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.

Other: Transfusion trigger based on experience

Interventions

Transfusion trigger based on WCPTS OTHER

Determination of whether a patient needs red blood cell transfusion or which hemoglobin level should be maintained is based on WCPTS

Transfusion trigger based on WCPTS

Maintenance of hemoglobin level more than 10g/dL OTHER

The patient's hemoglobin level is maintained more than 10g/dL perioperatively

Hemoglobin level 10g/dL

Transfusion trigger based on experience OTHER

Determination of whether the patient need red blood cell transfusion or which hemoglobin level should be maintained is based on the physician's experience

Transfusion trigger based on experience

Eligibility Criteria

• Age: 14 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Height of usual place of residence less than 2,500 metres above sea level
• Perioperative hemoglobin level possibly less than 10g/dL

You may not qualify if:

• Emergency operation
• ASA classification V or VI
• Serious blood system diseases
• Dysfunction of hemoglobin
• Hypervolemic hemodilution
• Tumor metastasis
• Psychopathy
• Refuse to sign consent

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

Department of Anesthesiology, West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

Related Publications (1)

• 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.

  PMID: 37052133 DERIVED

Study Officials

• Ren Liao, M.D.

  Department of Anesthesiology, West China Hospital, Sichuan University

  STUDY DIRECTOR

• Jin Liu, M.D.

  Department of Anesthesiology, West China Hospital, Sichuan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 9, 2012
• First Posted: May 11, 2012
• Study Start: May 7, 2012
• Primary Completion: January 20, 2017
• Study Completion: February 18, 2019
• Last Updated: November 20, 2019

Record last verified: 2019-11

Locations

CN (1)