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Clinic Trial for West China Perioperative Transfusion Score (WCPTS) (WCPTS)

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ClinicalTrials.gov Identifier: NCT01597232
Recruitment Status : Enrolling by invitation
First Posted : May 11, 2012
Last Update Posted : January 12, 2016
Sponsor:
Information provided by (Responsible Party):
Ren Liao, West China Hospital

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.


Condition or disease Intervention/treatment Phase
Transfusion Related Complications Other: Transfusion trigger based on WCPTS Other: Maintenance of hemoglobin level more than 10g/dL Other: Transfusion trigger based on experience Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Study Start Date : June 2012
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

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U.S. FDA Resources

Arm Intervention/treatment
Experimental: Transfusion trigger based on WCPTS
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
Determination of whether a patient needs red blood cell transfusion or which hemoglobin level should be maintained is based on WCPTS
Active Comparator: Hemoglobin level 10g/dL
The patient's hemoglobin level is maintained more than 10g/dL perioperatively.
Other: Maintenance of hemoglobin level more than 10g/dL
The patient's hemoglobin level is maintained more than 10g/dL perioperatively
Active Comparator: Transfusion trigger based on experience
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
Determination of whether the patient need red blood cell transfusion or which hemoglobin level should be maintained is based on the physician's experience



Primary Outcome Measures :
  1. Incidence of death and serious complications [ Time Frame: one year postoperatively ]
  2. Transfusion rate and transfusion volume of red blood cells [ Time Frame: one year postoperatively ]

Secondary Outcome Measures :
  1. Length of ICU stay [ Time Frame: one year postoperatively ]
  2. Hemoglobin level postoperatively [ Time Frame: 30 days postoperatively ]
  3. Healing of surgical incision [ Time Frame: 30 days postoperatively ]
  4. Length of hospitalization [ Time Frame: one year postoperatively ]
  5. Cost of transfusion and hospitalization [ Time Frame: one year postoperatively ]
  6. Quality of life [ Time Frame: one year postoperatively ]


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Ages Eligible for Study:   14 Years to 99 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01597232


Locations
China, Sichuan
Department of Anesthesiology, West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Sponsors and Collaborators
West China Hospital
Investigators
Study Director: Ren Liao, M.D. Department of Anesthesiology, West China Hospital, Sichuan University
Principal Investigator: Jin Liu, M.D. Department of Anesthesiology, West China Hospital, Sichuan University

Responsible Party: Ren Liao, Associate Professor, West China Hospital
ClinicalTrials.gov Identifier: NCT01597232     History of Changes
Other Study ID Numbers: WCPTS120508
First Posted: May 11, 2012    Key Record Dates
Last Update Posted: January 12, 2016
Last Verified: January 2016

Keywords provided by Ren Liao, West China Hospital:
Transfusion trigger
Hemoglobin level