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West-China Transfusion Score for Critically-ill Patients

Primary Purpose

Transfusion Related Complication, Critical Illness

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
RBC transfusion based on different protocols
Sponsored by
West China Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Transfusion Related Complication focused on measuring transfusion, trigger, critically-ill

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant women
  • Age less than 18
  • Serious blood system diseases
  • Dysfunction of hemoglobin
  • Tumor metastasis
  • Psychopathy
  • Refuse to sign consent

Sites / Locations

  • West China Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Transfusion trigger based on WCTS-CP

Transfusion trigger based on experience

Arm Description

Determination of whether a patient need red blood cells transfusion or which hemoglobin level should be maintained is based on WCTS-CP

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

Outcomes

Primary Outcome Measures

Incidence of death and serious complications

Secondary Outcome Measures

Transfusion rate and transfusion volume of red blood cells
ventilator-free days in 28 days
The time that patients do not need ventilaton support
length of stay in ICU or in hospital

Full Information

First Posted
May 11, 2014
Last Updated
May 13, 2014
Sponsor
West China Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02139995
Brief Title
West-China Transfusion Score for Critically-ill Patients
Official Title
West-China Transfusion Score for Critically-ill Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 doctors. 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 inotropic drugs for maintaining normal cardiac output, fraction of inspired oxygen, core temperature, and torlerance to anemia. To verify this hypothesis, the investigators present West China Transfusion Score for Critically-ill Patients(WCTS-CP) 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
Anemia is a common phenomenon in critically ill patients, and blood transfusion may provide guarantee for oxygen delivery. 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 specific doctors. Index of transfusion trigger for critically ill 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 inotropic drugs for maintaining normal cardiac output, fraction of inspired oxygen for maintaining saturation of oxygen≧95%, core temperature, and torlerance to anemia. The investigators set down the West China Transfusion Score for Critically-ill Patients(WCTS-CP) ,the initial score is 6. If a patient's cardiac output is normal without infusion of inotropic drugs, the heartbeat less than 100 per minute,his saturation of oxygen could be maintained more than 95%, his core temperature is less than 38℃, and he has no history of ischemic cardiovascular disease , and he is below 55 of age,his score is 6. If a patient has one or more problems, his score should be added 1 point for each problem. The initial WCTS-CP 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transfusion Related Complication, Critical Illness
Keywords
transfusion, trigger, critically-ill

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transfusion trigger based on WCTS-CP
Arm Type
Experimental
Arm Description
Determination of whether a patient need red blood cells transfusion or which hemoglobin level should be maintained is based on WCTS-CP
Arm Title
Transfusion trigger based on experience
Arm Type
Active Comparator
Arm Description
Determination of whether a patient need red blood cell transfusion or which hemoglobin level should be maintained is base on the physician's experience
Intervention Type
Behavioral
Intervention Name(s)
RBC transfusion based on different protocols
Intervention Description
transfusion trigger for experimental group is the WCTS-CP;for active comparator is the physician's experience
Primary Outcome Measure Information:
Title
Incidence of death and serious complications
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Transfusion rate and transfusion volume of red blood cells
Time Frame
28 days
Title
ventilator-free days in 28 days
Description
The time that patients do not need ventilaton support
Time Frame
28 days
Title
length of stay in ICU or in hospital
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Height of usual place of residence less than 2,500 metres above sea level Hemoglobin level possibly less than 10g/dL Exclusion Criteria: Pregnant women Age less than 18 Serious blood system diseases Dysfunction of hemoglobin Tumor metastasis Psychopathy Refuse to sign consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jin Liu, M.D
Phone
18980601539
First Name & Middle Initial & Last Name or Official Title & Degree
Yun yi Deng, M.D
Phone
18980602139
Email
dengyiyun1@medmail.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Liu, M.D
Organizational Affiliation
West China Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
West China Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China

12. IPD Sharing Statement

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West-China Transfusion Score for Critically-ill Patients

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