West-China Transfusion Score for Critically-ill Patients

Critical Illness Clinical Trial

Official title:

West-China Transfusion Score for Critically-ill Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02139995
• Other study ID #: Ethics-42
• Status: Not yet recruiting
• Phase: Phase 3
• First received: May 11, 2014
• Last updated: May 13, 2014
• Start date: May 2014
• Est. completion date: December 2014

Study information

• Verified date: May 2014
• Source: West China Hospital
• Contact: Jin Liu, M.D
• Phone: 18980601539
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Transfusion Related Complication

Intervention

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

Locations

Country	Name	City	State
China	West China Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of death and serious complications		28 days	Yes
Secondary	Transfusion rate and transfusion volume of red blood cells		28 days	Yes
Secondary	ventilator-free days in 28 days	The time that patients do not need ventilaton support	28 days	Yes
Secondary	length of stay in ICU or in hospital		28 days	Yes