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Clinic Trial for West China Perioperative Transfusion Score (WCPTS) (WCPTS)

18. november 2019 oppdatert av: Ren Liao, West China Hospital

Effect of West China Perioperative Transfusion Score (WCPTS) on Red Blood Cells Transfusion in Patients Undergoing Major Surgery: a Prospective, Multicenter, Randomized Controlled Trial

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 anesthesiologists or surgeons. 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 adrenalin for maintaining normal cardiac output, fraction of inspired oxygen, core temperature, and angina. To verify this hypothesis, the investigators present West China Perioperative Transfusion Score (WCPTS) 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.

Studieoversikt

Detaljert beskrivelse

Surgery and trauma are the most common reasons for major blood loss, and blood transfusion provide guarantee for massive hemorrhagic surgery, especially orthopedic, cardiac, liver, and gynecologic procedures. 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 anesthesiologists or surgeons. 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 adrenalin for maintaining normal cardiac output, fraction of inspired oxygen for maintaining spO2≧95%, core temperature, and angina.

Peri-Operative Transfusion Trigger Score, POTTS The initial score is 6. If a patient's cardiac output is normal without infusion of adrenalin, his spO2 could be maintained more than 95% with FiO2≤35%, his core temperature is less than 38℃, and he has no angina, his score is 6.

If a patient has one or more problems, including his normal cardiac output should be maintained by infusion of adrenalin with its rate ≤0.05μg/kg.min, or his spO2 is maintained more than 95% with 36~50% FiO2, or his core temperature is between 38℃ to 40℃, or chest pain due to exercise,manual labor,or excitement, his score should be added 1 point for each problem.

If a patient has one or more problems, including his normal cardiac output should be maintained by infusion of adrenalin with its rate >0.06μg/kg.min, or his spO2 is maintained more than 95% with >51% FiO2, or his core temperature is >40℃, or sudden onset of chest pain at rest, his score should be added 2 point for each problem.

The initial POTTS 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.

For example, if a patient need ≤0.05μg/kg.min adrenalin to maintain his normal cardiac output (+1), his spO2 could be maintained more than 95% with FiO2≤35%, his core temperature is less than 38℃, and he has sudden onset of chest pain at rest (+2), his POTTS score could be calculated as 6 +1 (≤0.05μg/kg.min adrenalin to maintain his normal cardiac output) +2 (sudden onset of chest pain at rest), and his POTTS score is 9. That means this patient's transfusion trigger is 9g/dL, and his hemoglobin level should be maintained above 9 at this situation.

Studietype

Intervensjonell

Registrering (Faktiske)

1351

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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Studiesteder

    • Sichuan
      • Chengdu, Sichuan, Kina, 610041
        • Department of Anesthesiology, West China Hospital, Sichuan University

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

14 år til 99 år (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

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

Exclusion Criteria:

  • Emergency operation
  • ASA classification V or VI
  • Serious blood system diseases
  • Dysfunction of hemoglobin
  • Hypervolemic hemodilution
  • Tumor metastasis
  • Psychopathy
  • Refuse to sign consent

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Transfusion trigger based on WCPTS
Determination of whether a patient need red blood cells transfusion or which hemoglobin level should be maintained is based on WCPTS.
Bestemmelse av om en pasient trenger transfusjon av røde blodlegemer eller hvilket hemoglobinnivå som skal opprettholdes er basert på WCPTS
Aktiv komparator: Hemoglobin level 10g/dL
The patient's hemoglobin level is maintained more than 10g/dL perioperatively.
The patient's hemoglobin level is maintained more than 10g/dL perioperatively
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.
Determination of whether the patient need red blood cell transfusion or which hemoglobin level should be maintained is based on the physician's experience

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion of patients received red-cell
Tidsramme: Up to 30 days postoperatively
Proportion of patients received red-cell during peri-operative period
Up to 30 days postoperatively
Composite of in-hospital complications and all-cause mortality by day-30
Tidsramme: Up to 30 days postoperatively
Composite of in-hospital complications and all-cause mortality by day-30, and complications were defined as the serious ones that cause prolonged hospitalization, or life threatening, but could get recovery after intense treatment during hospitalization, or life threatening, resulting in significantly decreased quality of life.
Up to 30 days postoperatively

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidences of in-hospital infectious complications.
Tidsramme: Up to 30 days postoperatively
Infectious complications were defined as infection at any site, such as pulmonary infection, urinary infection, etc.
Up to 30 days postoperatively
Intensive Care Unit (ICU) admission rate
Tidsramme: Up to 30 days postoperatively
Proportion of patients with ICU admission
Up to 30 days postoperatively
Length of hospital stay (LOS)
Tidsramme: Up to 30 days postoperatively
LOS was defined as the time frame from the day of hospital admission to discharge from the hospital (unit: days).
Up to 30 days postoperatively
Hemoglobin level at different time points
Tidsramme: Up to 30 days postoperatively
Hb level was measured at the time points as follows: before operation, completion of operation, 24hrs after operation, before discharge, and before all red cells transfusion
Up to 30 days postoperatively
Cost of transfusion and hospitalization
Tidsramme: Up to 30 days postoperatively
Allogeneic blood cost and total in-hospital cost
Up to 30 days postoperatively
SF-8 questionnaire
Tidsramme: Up to one year postoperatively
Follow-up of quality of life during one year after operation
Up to one year postoperatively
Healing status of surgical incision
Tidsramme: Up to 30 days postoperatively
Healing status of surgical incision was divided into grade Ⅰ, Ⅱ, and Ⅲ. Grade Ⅰ was defined as the wound healing nicely without any adverse reaction, grade Ⅱ was defined as the inflammatory wound without the need of re-incision, and grade Ⅲ was defined as the wound suppurated with the need of re-incision for clearance.
Up to 30 days postoperatively
All-cause mortality during 1-year after operation
Tidsramme: Up to one year postoperatively
All-cause mortality by day-60, day-180 and 1-year after operation
Up to one year postoperatively

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Studieleder: Ren Liao, M.D., Department of Anesthesiology, West China Hospital, Sichuan University
  • Hovedetterforsker: Jin Liu, M.D., Department of Anesthesiology, West China Hospital, Sichuan University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

7. mai 2012

Primær fullføring (Faktiske)

20. januar 2017

Studiet fullført (Faktiske)

18. februar 2019

Datoer for studieregistrering

Først innsendt

9. mai 2012

Først innsendt som oppfylte QC-kriteriene

10. mai 2012

Først lagt ut (Anslag)

11. mai 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. november 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. november 2019

Sist bekreftet

1. november 2019

Mer informasjon

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