West-China Transfusion Score for Critically-ill Patients

NCT02139995 | Unknown Phase 3

• 1 other identifier: Ethics-42
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Transfusion Related Complication; Critical Illness

Keywords

transfusion; trigger; critically-ill

Outcome Measures

Primary Outcomes (1)

• Incidence of death and serious complications

  28 days

Secondary Outcomes (3)

• Transfusion rate and transfusion volume of red blood cells

  28 days

• ventilator-free days in 28 days

  28 days

• length of stay in ICU or in hospital

  28 days

Study Arms (2)

Transfusion trigger based on WCTS-CP

EXPERIMENTAL

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 based on experience

ACTIVE COMPARATOR

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

Interventions

RBC transfusion based on different protocols BEHAVIORAL

transfusion trigger for experimental group is the WCTS-CP；for active comparator is the physician's experience

Transfusion trigger based on WCTS-CP; Transfusion trigger based on experience

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jin Liu, M.D

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin Liu, M.D

CONTACT

18980601539

Yun yi Deng, M.D

CONTACT

18980602139; dengyiyun1@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ICU

Study Record Dates

• First Submitted: May 11, 2014
• First Posted: May 16, 2014
• Study Start: May 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 16, 2014

Record last verified: 2014-05

Locations

CN (1)