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

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

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.

Study Overview

• Status: Completed
• Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm
• Intervention / Treatment: Other: Best Practice; Other: Medical Chart Review

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.

• Study Type: Observational
• Enrollment (Actual): 229

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient undergoing major cancer surgery with curative intent

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational (standard of care, medical chart review); Patients undergo standard of care treatment and their medical records are reviewed at 30 days and at 1 year after surgery.	Other: Best Practice; Undergo standard of care; Other Names: standard of care; standard therapy; Other: Medical Chart Review; Medical charts reviewed; Other Names: Chart Review

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Juan P Cata, M.D. Anderson Cancer Center

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2020
• Primary Completion (Actual): November 17, 2023
• Study Completion (Actual): November 17, 2023

Study Registration Dates

• First Submitted: July 14, 2020
• First Submitted That Met QC Criteria: July 27, 2020
• First Posted (Actual): July 29, 2020

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 2020-0130 (Other Identifier: M D Anderson Cancer Center); NCI-2020-04546 (Registry Identifier: CTRP (Clinical Trial Reporting Program))