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West-China Transfusion Score for Critically-ill Patients

13. maj 2014 opdateret af: Yiyun Deng, West China Hospital

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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

100

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Sichuan
      • Chengdu, Sichuan, Kina, 610041
        • West China Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
transfusion trigger for experimental group is the WCTS-CP;for active comparator is the physician's experience
Aktiv komparator: 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
transfusion trigger for experimental group is the WCTS-CP;for active comparator is the physician's experience

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Incidence of death and serious complications
Tidsramme: 28 days
28 days

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Jin Liu, M.D, West China Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2014

Primær færdiggørelse (Forventet)

1. september 2014

Studieafslutning (Forventet)

1. december 2014

Datoer for studieregistrering

Først indsendt

11. maj 2014

Først indsendt, der opfyldte QC-kriterier

13. maj 2014

Først opslået (Skøn)

16. maj 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

16. maj 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. maj 2014

Sidst verificeret

1. maj 2014

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Ethics-42

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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