Hematopoietic and Lymphoid Cell NeoplasmNCT04491409
Perioperative Care in the Cancer Patient -1, ARCA-1 Study
An observational study of Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Best Practice and Medical Chart Review
- How many people
- 229 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2020to 17 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient undergoing major cancer surgery with curative intent
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ARCA-1 Study: Perioperative Care in the Cancer Patient -1
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate if perioperative blood transfusions are associated with 1-year mortality.
SECONDARY OBJECTIVES:
- 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.
- Being tested
- Best Practice, Medical Chart Review
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Undergo standard of care
Medical Chart ReviewOther
Also called Chart Review
Medical charts reviewed
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Best Practice; Other: Medical Chart Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
All causes of mortality
Measured: 1 year after major oncologic non-cardiac surgery
Secondary outcomes (4)
Cancer-specific mortality
Measured: 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.
Measured: 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
Measured: 30 days after major oncologic non-cardiac surgery
Rate of perioperative blood products transfusion
Measured: During surgery and up to 2 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start3 Aug 2020
- Primary completion17 Nov 2023
- Study completion17 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hematopoietic and Lymphoid Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Juan P Cata, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04491409
- Sponsor's protocol ID
- 2020-0130
- Other IDs
- NCI-2020-04546, 2020-0130
- Status last verified
- Nov 2023
- First submitted
- 14 Jul 2020
- Last updated
- 21 Nov 2023
- Results posted
- No
Publications
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.
PubMed 39504267Cata 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.
PubMed 33737431
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARCA-1 Study: Perioperative Care in the Cancer Patient -1
- ClinicalTrials.gov ID
- NCT04491409
- Acronym / sponsor ID
- 2020-0130
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 17 Nov 2023 (actual)
- Study completion
- 17 Nov 2023 (actual)
- First posted
- 29 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To evaluate if perioperative blood transfusions are associated with 1-year mortality.
SECONDARY OBJECTIVES:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (standard of care, medical chart review) | – | Other: Best Practice, Other: Medical Chart ReviewPatients undergo standard of care treatment and their medical records are reviewed at 30 days and at 1 year after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient undergoing major cancer surgery with curative intent
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyUndergo standard of care | Other | Observational (standard of care, medical chart review) |
| Medical Chart ReviewAlso: Chart ReviewMedical charts reviewed | Other | Observational (standard of care, medical chart review) |
Primary outcome
All causes of mortality
Time frame: 1 year after major oncologic non-cardiac surgery
4 secondary outcomes
Cancer-specific mortality
Time frame: 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
30 days mortality
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Derived from this study: PubMed 39504267Cata 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.
- Derived from this study: PubMed 33737431Cata 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan P Cata principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All causes of mortality (time frame: 1 year after major oncologic non-cardiac surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04491409, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.