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

18 novembre 2019 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

1351

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 14 anni a 99 anni (Bambino, Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
La determinazione se un paziente necessita di trasfusioni di globuli rossi o quale livello di emoglobina deve essere mantenuto si basa sul WCPTS
Comparatore attivo: 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
Comparatore attivo: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of patients received red-cell
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidences of in-hospital infectious complications.
Lasso di tempo: 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
Lasso di tempo: Up to 30 days postoperatively
Proportion of patients with ICU admission
Up to 30 days postoperatively
Length of hospital stay (LOS)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Up to 30 days postoperatively
Allogeneic blood cost and total in-hospital cost
Up to 30 days postoperatively
SF-8 questionnaire
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Up to one year postoperatively
All-cause mortality by day-60, day-180 and 1-year after operation
Up to one year postoperatively

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Direttore dello studio: Ren Liao, M.D., Department of Anesthesiology, West China Hospital, Sichuan University
  • Investigatore principale: Jin Liu, M.D., Department of Anesthesiology, West China Hospital, Sichuan University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

7 maggio 2012

Completamento primario (Effettivo)

20 gennaio 2017

Completamento dello studio (Effettivo)

18 febbraio 2019

Date di iscrizione allo studio

Primo inviato

9 maggio 2012

Primo inviato che soddisfa i criteri di controllo qualità

10 maggio 2012

Primo Inserito (Stima)

11 maggio 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

20 novembre 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 novembre 2019

Ultimo verificato

1 novembre 2019

Maggiori informazioni

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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