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West-China Transfusion Score for Critically-ill Patients

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ClinicalTrials.gov Identifier: NCT02139995
Recruitment Status : Unknown
Verified May 2014 by Yiyun Deng, West China Hospital.
Recruitment status was:  Not yet recruiting
First Posted : May 16, 2014
Last Update Posted : May 16, 2014
Sponsor:
Information provided by (Responsible Party):
Yiyun Deng, 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 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.


Condition or disease Intervention/treatment Phase
Transfusion Related Complication Critical Illness Behavioral: RBC transfusion based on different protocols Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: West-China Transfusion Score for Critically-ill Patients
Study Start Date : May 2014
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Transfusion trigger based on WCTS-CP
Determination of whether a patient need red blood cells transfusion or which hemoglobin level should be maintained is based on WCTS-CP
Behavioral: RBC transfusion based on different protocols
transfusion trigger for experimental group is the WCTS-CP;for active comparator is the physician's experience

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
Behavioral: RBC transfusion based on different protocols
transfusion trigger for experimental group is the WCTS-CP;for active comparator is the physician's experience




Primary Outcome Measures :
  1. Incidence of death and serious complications [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Transfusion rate and transfusion volume of red blood cells [ Time Frame: 28 days ]
  2. ventilator-free days in 28 days [ Time Frame: 28 days ]
    The time that patients do not need ventilaton support

  3. length of stay in ICU or in hospital [ Time Frame: 28 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
  • 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

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): NCT02139995


Contacts
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Contact: Jin Liu, M.D 18980601539
Contact: Yun yi Deng, M.D 18980602139 dengyiyun1@medmail.com.cn

Locations
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China, Sichuan
West China Hospital
Chengdu, Sichuan, China, 610041
Sponsors and Collaborators
West China Hospital
Investigators
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Principal Investigator: Jin Liu, M.D West China Hospital
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Responsible Party: Yiyun Deng, ICU, West China Hospital
ClinicalTrials.gov Identifier: NCT02139995    
Other Study ID Numbers: Ethics-42
First Posted: May 16, 2014    Key Record Dates
Last Update Posted: May 16, 2014
Last Verified: May 2014
Keywords provided by Yiyun Deng, West China Hospital:
transfusion
trigger
critically-ill
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes