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

Malignant Solid Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04491409
• Other study ID #: 2020-0130
• Secondary ID: NCI-2020-0454620
• Status: Completed
• Start date: August 3, 2020
• Est. completion date: November 17, 2023

Study information

• Verified date: November 2023
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 229
• Est. completion date: November 17, 2023
• Est. primary completion date: November 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematopoietic and Lymphoid Cell Neoplasm
• Malignant Solid Neoplasm
• Neoplasms

Intervention

Other:
• Best Practice
Undergo standard of care
• Medical Chart Review
Medical charts reviewed

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All causes of mortality		1 year after major oncologic non-cardiac surgery
Secondary	Cancer-specific mortality		1 year after major oncologic non-cardiac surgery
Secondary	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
Secondary	30 days mortality		30 days after major oncologic non-cardiac surgery
Secondary	Rate of perioperative blood products transfusion		During surgery and up to 2 weeks post surgery

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