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

Study Overview
=================
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.

Official Title
-----------------
ARCA-1 Study: Perioperative Care in the Cancer Patient -1

Conditions
-----------------
Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

Intervention / Treatment
-----------------
* Other: Best Practice
* Other: Medical Chart Review


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient undergoing major cancer surgery with curative intent Planned length of stay 24 hours after surgery or longer American Society of Anesthesiologists physical status (ASA) 1-4 Scheduled, non-emergency surgery 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (standard of care, medical chart review)<br>Patients undergo standard of care treatment and their medical records are reviewed at 30 days and at 1 year after surgery. | Other: Best Practice<br>* Undergo standard of care<br>* Other names: standard therapy;Other: Medical Chart Review<br>* Medical charts reviewed<br>* Other names: Chart Review;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All causes of mortality |  | 1 year after major oncologic non-cardiac surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer-specific mortality |  | 1 year after major oncologic non-cardiac surgery | 
| Progression free survival (PFS) | 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. | 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 | 
| 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 |