Skip to main content
OpenTrials
Completed

NCT Number: NCT04491409

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hematopoietic and Lymphoid Cell Neoplasm Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Malignant Solid Neoplasm Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Best Practice

Other

Undergo standard of care

Other names: standard of care, standard therapy

medical chart review

Other

Medical charts reviewed

Other names: Chart Review

Primary outcomes

  1. All causes of mortality

    Time frame: 1 year after major oncologic non-cardiac surgery

Secondary outcomes

  1. Cancer-specific mortality

    Time frame: 1 year after major oncologic non-cardiac surgery

  2. Progression free survival (PFS)

    Time frame: 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

    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.

  3. 30 days mortality

    Time frame: 30 days after major oncologic non-cardiac surgery

  4. Rate of perioperative blood products transfusion

    Time frame: During surgery and up to 2 weeks post surgery

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 29, 2020
Registry last updated
Nov 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.