VA Cooperative Studies Program (CSP)

Investigator Access

What's Available

Check with the study contact and publications for information on a public dataset, data archive, data enclave, or website where data might be available.

Available Documentation

Dates Data are Available

Access Criteria

Study Characteristics

Objectives

To determine whether a liberal transfusion strategy (transfusion trigger at Hb < 10 gm/dl) in Veterans at high cardiac risk who undergo major open vascular and general surgery operations is associated with decreased risk of adverse postoperative outcomes compared to a restrictive transfusion strategy (transfusion trigger at Hb < 7 gm/dl).

Era of Service

All

Population

Inclusion Criteria

• Males and females older than 18 years of age who have postoperative Hb < 10 gm/dl within 15 days after the index operation
• Patients who undergo an operation in either one of the three following categories, regardless of their preoperative Hb level, and regardless of preoperative or intraoperative transfusion they might have received:
     o  Veterans who undergo peripheral artery disease (PAD)-related operations
     o  Veterans with past medical history of ischemic stroke or ischemic heart disease (IHD) or PAD who undergo general surgery procedures
     o  Veterans with past medical history of ischemic stroke or IHD or PAD who undergo Vascular Surgery operations
  
  

Exclusion Criteria

• Unable to consent or unwilling to follow protocol, such as Jehovah’s witnesses
• Known history of hereditary anemias such as Thalassemia or Sickle cell disease; known history of hereditary bleeding disorders, such as factor VIII or factor IX deficiency; or prior history of adverse reaction to blood administration, such as fever, rash, or hemolysis
• Doesn’t speak or understand English
• Hemodynamically unstable or in cardiogenic shock
• Participating in another interventional trial whose objective is to evaluate the effect of transfusion on outcomes, or prior randomization in CSP #599
• Pregnancy 
• Prisoner or in custody of law enforcement

Study Design

Randomized, intent-to-treat, two-arm, parallel design, single-blind, multicenter trial

Time Period

2018 – 2022

Setting

National (15 VA Medical Centers)

N

3,070 participants

Response Rate

Recruitment ongoing

Recruitment Method

Unconfirmed

Compensation

Unconfirmed

Data Collected

• Length of hospital stay
• All-cause mortality at 1 year after randomization (myocardial infarction (MI), coronary revascularization, acute renal failure, or postoperative ischemic stroke)
• A composite endpoint (up to 90 days after randomization) of:     
     o  All-cause post-randomization mortality
     o  MI
     o  Coronary revascularization
     o  Acute renal failure
     o  Post-randomization ischemic stroke
     o  New cardiac arrhythmias that necessitate new treatment
     o  New or worsening congestive heart failure (CHF)
     o  Cardiac arrest

Data Collection Methods

• Assessments will be collected pre/post-operatively and at discharge, or at 30 days after randomization if the patient is still hospitalized
• Follow up forms will be filled out during a clinic visit after the 30th and 90th post-randomization day. Patients who cannot present to the clinic will have a phone call for follow up
• One year post-randomization mortality will be ascertained using electronic medical records, phone follow-up, and search of the national death index

Funding Source

VA Cooperative Studies Program (CSP)

Contact

Erin Norman, Leslie.Norman@va.gov

Selected Publications

Unconfirmed

More Information

ClinicalTrials.gov
ClinicalTrials.gov Identifier: NCT03229941
ClinicalTrials.ucsf.edu ¹