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

M.D. Anderson Cancer Center

Status

Completed

Conditions

Hematopoietic and Lymphoid Cell Neoplasm

Malignant Solid Neoplasm

Treatments

Other: Medical Chart Review

Other: Best Practice

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT04491409

NCI-2020-04546 (Registry Identifier)

2020-0130 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

229 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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