Clinical Trial of West-China Perioperative Transfusion Score (WCPTS)for Massive Hemorrhagic Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by West China Hospital
Sponsor:
Information provided by (Responsible Party):
Liu Jin, West China Hospital, Sichuan University
ClinicalTrials.gov Identifier:
NCT01345643
First received: April 26, 2011
Last updated: April 5, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Transfusion Related Complications
Other: Maintenance of hemoglobin level not less than 10g/dL
Other: Transfusion trigger based on WCPTS
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Clinical Trial of Transfusion Under the Guidance of West-China Perioperative Transfusion Score(WCPTS)for Massive Hemorrhagic Surgery

Resource links provided by NLM:


Further study details as provided by West China Hospital:

Primary Outcome Measures:
  • Rate of red blood cells transfusion [ Time Frame: one year postoperatively ] [ Designated as safety issue: Yes ]
  • Transfusion volume of red blood cells [ Time Frame: One year postoperatively ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidences of death and serious complications [ Time Frame: one year postoperatively ] [ Designated as safety issue: Yes ]
    Compare the incidences of death and complications, including postoperative bleeding, re-operation, cardiac events (cardiac ischemia, myocardial infarction,etc.), pulmonary events (infection, desaturation, etc.), transfusion related events (allergic reaction, hemolytic reaction, etc.), and others

  • Healing of surgical incision [ Time Frame: one year postoperatively ] [ Designated as safety issue: Yes ]
  • Time to get recovery of daily life and/or working [ Time Frame: one year postoperatively ] [ Designated as safety issue: Yes ]
  • Length of ICU stay and hospitalization [ Time Frame: one year postoperatively ] [ Designated as safety issue: Yes ]
  • Cost of hospitalization and transfusion [ Time Frame: one year postoperatively ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: February 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hemoglobin level based on WCPT Score
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.
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 100g/L
The patient's hemoglobin level is maintained not less than 10g/dL perioperatively.
Other: Maintenance of hemoglobin level not less than 10g/dL
The patient's hemoglobin level is maintained not less than 10g/dL perioperatively.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients who sign the consent, with Glasgow Coma Scale (GCS) score of 15, undergoing surgery which blood loss could be more than 800ml or 20% of the patient's whole blood volume.

Exclusion Criteria:

  • Pregnancy
  • Psychopathy
  • Refuse to sign consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01345643

Contacts
Contact: Ren Liao, M.D. +86-18980602177 liaoren7733@gmail.com
Contact: Jin Liu, M.D. +86-28-85422520 scujinliu@gmail.com

Locations
China, Sichuan
West China Hosptial, Sichuan University Recruiting
Chengdu, Sichuan, China, 610041
Contact: Ren Liao, M.D.    +86-18980602177    liaoren7733@gmail.com   
Contact: Jin Liu, M.D.    +86-28-85422520    scujinliu@gmail.com   
Sponsors and Collaborators
Liu Jin
Investigators
Study Director: Ren Liao, M.D. Department of Anesthesiology, West China Hospital, Sichuan University
Study Chair: Jin Liu, M.D. Department of Anesthesiology, West China Hospital, Sichuan University
  More Information

No publications provided

Responsible Party: Liu Jin, Chief of Department of Anesthesiology, West China Hospital, Sichuan University
ClinicalTrials.gov Identifier: NCT01345643     History of Changes
Other Study ID Numbers: WCPTS110419
Study First Received: April 26, 2011
Last Updated: April 5, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by West China Hospital:
Transfusion
Hemoglobin level

ClinicalTrials.gov processed this record on September 30, 2014