- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04491409
Perioperative Care in the Cancer Patient -1, ARCA-1 Study
ARCA-1 Study: Perioperative Care in the Cancer Patient -1
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Juan P. Cata
- Phone Number: 713-792-7452
- Email: jcata@mdanderson.org
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
Undergo standard of care
Other Names:
Medical charts reviewed
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
All causes of mortality
Time Frame: 1 year after major oncologic non-cardiac surgery
|
1 year after major oncologic non-cardiac surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cancer-specific mortality
Time Frame: 1 year after major oncologic non-cardiac surgery
|
1 year after major oncologic non-cardiac surgery
|
|
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.
|
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
Time Frame: 30 days after major oncologic non-cardiac surgery
|
30 days after major oncologic non-cardiac surgery
|
|
Rate of perioperative blood products transfusion
Time Frame: During surgery and up to 2 weeks post surgery
|
During surgery and up to 2 weeks post surgery
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Juan P Cata, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-0130 (Other Identifier: M D Anderson Cancer Center)
- NCI-2020-04546 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hematopoietic and Lymphoid Cell Neoplasm
-
University of California, San FranciscoLazarex Cancer FoundationTerminatedHematopoietic and Lymphoid Cell Neoplasm | Malignant NeoplasmUnited States
-
OHSU Knight Cancer InstituteNational Cancer Institute (NCI); Oregon Health and Science UniversityRecruitingHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid NeoplasmUnited States
-
Mayo ClinicRecruitingHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid NeoplasmUnited States
-
M.D. Anderson Cancer CenterRecruitingHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid NeoplasmUnited States
-
Mayo ClinicNational Cancer Institute (NCI)RecruitingHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid NeoplasmUnited States
-
Ohio State University Comprehensive Cancer CenterActive, not recruitingHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid NeoplasmUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid NeoplasmUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid NeoplasmUnited States
-
M.D. Anderson Cancer CenterWithdrawnHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid NeoplasmUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid NeoplasmUnited States
Clinical Trials on Best Practice
-
Emory UniversityNational Cancer Institute (NCI); National Center for Complementary and Integrative...RecruitingLymphoma | Multiple MyelomaUnited States
-
University of Massachusetts, WorcesterUniversity of FloridaEnrolling by invitationAtrial FibrillationUnited States
-
Sunnybrook Health Sciences CentreCanadian Institutes of Health Research (CIHR); Institute for Clinical Evaluative... and other collaboratorsCompletedHypertension | Diabetes | Ischemic Heart DiseaseCanada
-
University of California, San FranciscoCompleted
-
Brigham and Women's HospitalNational Heart, Lung, and Blood Institute (NHLBI)Not yet recruitingHypertension | Primary Aldosteronism | Hyperaldosteronism | Resistant Hypertension | Mineralocorticoid Excess | Secondary HypertensionUnited States
-
University of North Carolina, Chapel HillNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)RecruitingDiabetes Mellitus, Type 2United States
-
Marmara UniversityUnknown
-
University of UtahRecruitingAnemia | Thrombocytopenia | Coagulopathy, Mild | HypofibrinogenemiaUnited States
-
Geisinger ClinicCompletedHypercholesterolemia | Hypercholesterolemia, Familial | Hypercholesteremia in Children | Hyperlipidemia in ChildrenUnited States
-
St. Antonius HospitalDutch Cancer SocietyUnknownPancreatic Neoplasms | Pancreatic Cancer | Pancreatic Diseases | PancreatitisNetherlands