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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

229 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-03

Study Completion Date

2023-11-17

Brief Summary

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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.

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Detailed Description

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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

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Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Best Practice

Intervention Type OTHER

Undergo standard of care

Medical Chart Review

Intervention Type OTHER

Medical charts reviewed

Interventions

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Best Practice

Undergo standard of care

Intervention Type OTHER

Medical Chart Review

Medical charts reviewed

Intervention Type OTHER

Other Intervention Names

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standard of care standard therapy Chart Review

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No