Perioperative Care in the Cancer Patient -1, ARCA-1 Study

Completed

Conditions: Malignant Solid Neoplasm
Hematopoietic and Lymphoid Cell Neoplasm

Brief Summary: This study investigates the association of blood transfusions given around the time of surgery (perioperative) with complications after surgery (postoperative), cancer progression, and mortality after major oncologic non-cardiac surgery. The administration of blood products is an important clinical therapy to treat life-threatening blood (hematological) disorders (i.e. anemia, coagulation disorders or thrombocytopenia) in patients with cancer undergoing major non-cardiac surgery. On the other hand, the unnecessary exposure of those patients to blood products can be associated with the occurrence of unwanted severe complications and potentially increase the risk of death. An accurate understanding of the short and long-term outcomes, the patterns of blood transfusions, and the triggers of blood product administration may help researchers design and test the safety of perioperative blood transfusions in patients with cancer.

Detailed Description: PRIMARY OBJECTIVE:

I. To evaluate if perioperative blood transfusions are associated with 1-year mortality.

SECONDARY OBJECTIVES:

I. To evaluate the association of blood transfusion with postoperative complications, 30 days mortality and cancer progression after major oncologic non-cardiac surgery.

II. To gain knowledge on prevalence and patterns of blood product administration worldwide, the incidence and management of perioperative anemia and the incidence and treatment of perioperative coagulopathies.

OUTLINE:

Patients undergo standard of care treatment and their medical records are reviewed at 30 days and at 1 year after surgery.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Emergency surgery
Palliative surgeries for metastatic disease (non-curative intent)
Patients undergoing surgery with minimum risk (< 1%) of blood transfusion according to each center practice (i.e. simple mastectomy, thyroidectomies or wide-local excisions)
Patients undergoing surgery under local anesthesia
Patients undergoing ambulatory surgery or planned hospital admission of less than 24 hours

Arm && Interventions

Group	Intervention	Description
Observational (standard of care, medical chart review)	Best Practice	Patients undergo standard of care treatment and their medical records are reviewed at 30 days and at 1 year after surgery.
Observational (standard of care, medical chart review)	Medical Chart Review	Patients undergo standard of care treatment and their medical records are reviewed at 30 days and at 1 year after surgery.

Primary Outcome Measures

Name	Time	Method
All causes of mortality	1 year after major oncologic non-cardiac surgery

Secondary Outcome Measures

Name	Time	Method
Cancer-specific mortality	1 year after major oncologic non-cardiac surgery
Progression free survival (PFS)	From the date of surgery to the date of progression or death whichever happened first, assessed at 1 year after major oncologic non-cardiac surgery	Kaplan-Meier method will be used to estimate the PFS, and the log-rank test will be used to evaluate the difference in PFS between the RBCT group and non-RBCT group. PFS rate at 1 year will be reported. Multivariable Cox proportional hazards models may be used to evaluate the effect of RBCT on PFS with the adjustment of other important covariates.
30 days mortality	30 days after major oncologic non-cardiac surgery
Rate of perioperative blood products transfusion	During surgery and up to 2 weeks post surgery

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