NCT04491409

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 229 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Hematopoietic and Lymphoid Cell Neoplasm
• Malignant Solid Neoplasm

Interventions

Type	Name	Description
OTHER	Best Practice	Undergo standard of care
OTHER	Medical Chart Review	Medical charts reviewed

Timeline

• Start date: 2020-08-03
• Primary completion: 2023-11-17
• Completion: 2023-11-17
• First posted: 2020-07-29
• Last updated: 2023-11-21

Locations

1 site across 1 country: United States