Status:

UNKNOWN

Transfusional Trigger in Post-operative Oncologic Patients in Critical Care

Lead Sponsor:

AC Camargo Cancer Center

Conditions:

Transfusion

Oncology

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Transfusional practices evolved significantly over the last decades, but there are still important controversies regarding triggers that should be adopted in different clinical scenarios. Most interna...

Detailed Description

Randomization: patients will be randomized in a 1:1 ratio to one of the transfusion strategies, stratified according to age ≤65 years or \> 65 years. Monitoring and follow-up: Study investigators wil...

Eligibility Criteria

Inclusion

  • Patient with a solid tumor and age ≥ 18 years
  • Admission to the ICU due to postoperative care after being submitted to a major surgical procedure (defined as having a duration of three hours or more)
  • Expected ICU stay of more than 24 hours
  • Presenting Hb value of 9,0g/dL or less during ICU stay, within the first 7 days post-surgical procedure

Exclusion

  • Hematological malignancy
  • Chronic anemia (defined as presenting Hb ≤9,0g/dL at hospital admission and / or diagnosed hematological disease)
  • Presence of active bleeding at the moment of inclusion in the study (defined as visible bleeding with fall of 2,0g/dL in Hb levels in the last 12 hours or need to reoperate)
  • Transfusion of RBC during the current ICU stay before the inclusion in the study
  • Patient refusal to receive blood transfusions
  • Pregnancy
  • Postoperative care of cardiac surgery or surgery for correction of hip fracture
  • Patients with terminal oncological disease in palliative care
  • Arterial ischemic event in the current hospital stay or in the past twelve months (includes stroke, myocardial infarction, unstable angina, mesenteric ischemia, peripheral ischemia)

Key Trial Info

Start Date :

May 1 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 1 2022

Estimated Enrollment :

840 Patients enrolled

Trial Details

Trial ID

NCT04859855

Start Date

May 1 2021

End Date

August 1 2022

Last Update

May 19 2021

Active Locations (1)

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1

ACCamargoCC

São Paulo, São Paulo, Brazil, 01509900