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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-04546 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2020-0130 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Undergo standard of care |
|
| Measure | Description | Time Frame |
|---|---|---|
| All causes of mortality | 1 year after major oncologic non-cardiac surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Cancer-specific mortality | 1 year after major oncologic non-cardiac surgery | |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patient undergoing major cancer surgery with curative intent
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| Name | Affiliation | Role |
|---|---|---|
| Juan P Cata | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39504267 | Derived | 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. | |
| 33737431 |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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| Medical Chart Review | Other | Medical charts reviewed |
|
|
| 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 |
| 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. |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |