Clinical trial NCT04491409: Perioperative Care in the Cancer Patient -1, ARCA-1 Study
Official title: ARCA-1 Study: Perioperative Care in the Cancer Patient -1
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-07-29
Enrollment: 229
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient undergoing major cancer surgery with curative intent

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.

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

Primary outcomes:
measure: All causes of mortality
timeFrame: 1 year after major oncologic non-cardiac surgery
Secondary outcomes:
measure: Cancer-specific mortality
timeFrame: 1 year after major oncologic non-cardiac surgery
measure: Progression free survival (PFS)
timeFrame: 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
measure: 30 days mortality
timeFrame: 30 days after major oncologic non-cardiac surgery
measure: Rate of perioperative blood products transfusion
timeFrame: During surgery and up to 2 weeks post surgery
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Juan P Cata
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cata J, Ramirez M, Forget P, Chen LL, Diaz-Cambronero O, Chen W, Warner MA, Knopfelmacher Couchonal A, Pelosi P, Cuellar L, Corrales G, Romero C, Lobo F, Saager L, Castro Tapia J, Kiberenge R, Feng L, Serpa Neto A. International multicentre observational study to evaluate the association between perioperative red blood cell transfusions and 1-year mortality after major cancer surgery (ARCA-1): study design, statistical analysis plan and study protocol. BMJ Open. 2021 Mar 18;11(3):e043453. doi: 10.1136/bmjopen-2020-043453.