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

NCT04491409 | Completed

• 2 other identifiers: 2020-0130NCI-2020-04546
• Study Type: observational
• Target: 229
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (1)

• All causes of mortality

  1 year after major oncologic non-cardiac surgery

Secondary Outcomes (4)

• 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

• 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

Study Arms (1)

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; Other: Medical Chart Review

Interventions

Best Practice OTHER

Undergo standard of care

Also known as: standard of care, standard therapy

Observational (standard of care, medical chart review)

Medical Chart Review OTHER

Medical charts reviewed

Also known as: Chart Review

Observational (standard of care, medical chart review)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient undergoing major cancer surgery with curative intent

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (2)

• Cata JP, Guerra-Londono JJ, Ramirez MF, Chen LL, Warner MA, Guzman LFC, Lobo F, Uribe-Marquez S, Huang J, Ruscic KJ, Chew STH, Lanigan M; ARCA-1 Investigators. The Association Between Perioperative Red Blood Cell Transfusions and 1-Year Mortality After Major Cancer Surgery: An International Multicenter Observational Study. Anesth Analg. 2025 Apr 1;140(4):782-794. doi: 10.1213/ANE.0000000000007236. Epub 2024 Nov 6.

  PMID: 39504267 DERIVED

• 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.

  PMID: 33737431 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Study Officials

• Juan P Cata

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 29, 2020
• Study Start: August 3, 2020
• Primary Completion: November 17, 2023
• Study Completion: November 17, 2023
• Last Updated: November 21, 2023

Record last verified: 2023-11

Locations

US (1)