Know Cancer

or
forgot password

Transfusion Requirements in Critical Clinical Oncologic Patients: a Phase 3 Randomized Controlled Clinical Trial (TRICCOP STUDY)


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Anemia

Thank you

Trial Information

Transfusion Requirements in Critical Clinical Oncologic Patients: a Phase 3 Randomized Controlled Clinical Trial (TRICCOP STUDY)


Blood transfusion is commonly performed in critically ill patients, particularly in
oncologic patients. However, there are many studies reporting adverse effects of this
intervention and final data on benefits are not available. There are no prospective studies
in oncologic patients regarding red blood cell transfusions requirements. There are
observational and experimental studies suggesting worse outcomes including higher rates of
infection and other clinical complications, maybe higher cancer recurrence, in patients
submitted to red blood transfusion. Hemoglobin levels around 9 g/dL are usually recommended
although not based in evidence . The investigators purpose is to prospectively evaluate two
strategies of transfusion in 400 patients with cancer admitted to intensive care unit for
severe clinical condition: a liberal strategy - patients receive blood transfusion when
hemoglobin is lower than 9 g/dL since the admission to ICU until ICU discharge; a
restrictive strategy - patients receive blood transfusion only when hemoglobin is lower than
7 g/dL.

Clinical outcomes, costs and quality of life will be compared.


Inclusion Criteria:



- Adults patients with cancer admitted to ICU due to severe clinical condition AND

- Septic shock diagnosis AND

- Solid neoplasm AND

- Written informed consent

Exclusion Criteria:

- Age less than 18 years OR

- Leukemia or myelodysplastic syndrome OR

- Hematologic neoplasm OR

- Palliative treatment OR

- Renal Chronic Failure in Renal Replacement Therapy OR

- Karnofsky Status < 50 OR

- Previous thrombocytopenia (platelet number lower than 50.000/mm3) OR

- Previous known coagulopathy OR

- Life-threatening bleeding OR

- Documented wish against transfusion OR

- Patients who refused participation in the study

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To compare mortality between groups 28 day after ICU admission

Outcome Time Frame:

28 days after ICU admission

Safety Issue:

Yes

Principal Investigator

Paulo G. Hoff, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

ICESP - HCFMUSP

Authority:

Brazil: National Committee of Ethics in Research

Study ID:

FSB

NCT ID:

NCT01648946

Start Date:

June 2012

Completion Date:

June 2013

Related Keywords:

  • Anemia
  • Strategies of transfusion
  • Red blood cells
  • Liberal
  • Restrictive
  • Oncologic critically ill patients
  • Anemia
  • Critical Illness

Name

Location