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Transfusion Trigger After Operations in High Cardiac Risk Patients (TOP)

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ClinicalTrials.gov Identifier: NCT03229941
Recruitment Status : Recruiting
First Posted : July 26, 2017
Last Update Posted : October 27, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
The goal of the proposed study is 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).

Condition or disease Intervention/treatment Phase
Myocardial Infarction Coronary Revascularization Acute Renal Failure Procedure: Blood Transfusion Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3070 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: CSP #599 - Transfusion Trigger After Operations in High Cardiac Risk Patients (TOP)
Actual Study Start Date : February 5, 2018
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : February 28, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Restrictive
Transfusion trigger: Hb<7gm/dl
Procedure: Blood Transfusion
Blood Transfusion

Experimental: Liberal
Transfusion trigger: Hb<10gm/dl
Procedure: Blood Transfusion
Blood Transfusion




Primary Outcome Measures :
  1. A composite endpoint of all-cause post-randomization mortality, myocardial infarction (MI), coronary revascularization, acute renal failure, or post-randomization ischemic stroke up to 90 days after randomization. [ Time Frame: 90 days after randomization ]
    MI will be defined using the Third Universal Definition of Myocardial Infarction. Acute renal failure will be defined as Acute Kidney Injury stage III according to RIFLE criteria. Baseline creatinine will be considered the creatinine upon admission prior to the index operation. The above urine output criteria will be only used for patients who are in the ICU and have precise monitoring of their urinary output. For patients on the surgical floor only serum creatinine changes will be used for assessment of this endpoint. Coronary revascularization will be defined as a coronary artery bypass graft, or percutaneous coronary intervention (either angioplasty or stenting). Stroke will be defined as new unilateral neurological deficit that lasts for more than 24 hours, and is confirmed by a brain imaging modality (computed tomography or magnetic resonance imaging study) demonstrating new brain infarct.


Secondary Outcome Measures :
  1. A composite endpoint of postoperative infectious complications at 90 days post-randomization: Infectious complications will include wound infections, pneumonia, and sepsis. [ Time Frame: 90 days after randomization ]

    Wound infection will be defined according to the Centers for Disease Control and Prevention (CDC) guidelines as a) positive wound culture, or b) drainage of pus from a wound, or c) suspicion of wound infection that was drained operatively.

    Pneumonia will be defined according to the CDC definition as chest radiograph with new or progressive infiltrate, consolidation, cavitation, or pleural effusion and any of the following: new onset of purulent sputum or change in character of sputum, or organism isolated from blood culture, trans-tracheal aspirate, bronchial brushings, or biopsy.

    Sepsis will be defined as a combination of two of the following systemic inflammatory response syndrome (SIRS) criteria, plus suspected or present source of infection. SIRS criteria will include the following: temperature greater than 38C, heart rate greater than 90 beats/min, WBC > 12,000 or < 4,000, or > 10% bands.


  2. A composite endpoint of cardiac complications (other than MI) at 90 days post-randomization: Cardiac complications will include new cardiac arrhythmias that necessitate new treatment, new or worsening congestive heart failure (CHF), and cardiac arrest no [ Time Frame: 90 days after randomization ]

    The diagnosis of cardiac arrhythmias will be based on EKG findings. Only arrhythmias that result in initiation of new treatment regimen (to include medications, implantable devices, or surgical intervention) during hospitalization will be recorded.

    CHF will require at least one of the following symptoms or signs new or worsening: dyspnea at rest, orthopnea, or paroxysmal nocturnal dyspnea and radiological evidence of heart failure or worsening heart failure and increase/initiation of established treatment.

    Cardiac arrest will be defined as the cessation of cardiac pump function activity that results in loss of consciousness and absence of circulating blood flow as evidenced by absent carotid pulse. Only episodes of cardiac arrest that are reversed will be collected under this endpoint. If they are not reversed the event will be categorized as death.


  3. All-cause mortality at 1 year after randomization. [ Time Frame: 12 months after randomization ]
    The investigators will determine vital status by telephoning participants after hospital discharge, by searching the electronic medical record and the National Death Index.

  4. A composite endpoint of all-cause mortality, [ Time Frame: 30 days after randomization ]
    MI, coronary revascularization, acute renal failure, or postoperative ischemic stroke.

  5. Length of hospital stay. [ Time Frame: At hospital discharge, up to 1 year ]
    Length of hospital stay


Other Outcome Measures:
  1. The investigators will examine individual rates of the outcomes that consist of individual components of the primary endpoint. [ Time Frame: 90 days after randomization ]
    All cause postoperative mortality, Postoperative MI, Postoperative coronary revascularization, Postoperative stroke,Postoperative acute renal failure



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males and females older than 18 years of age who have postoperative Hb < 10gm/dl within 15 days after the index operation
  • Patients who undergo an operation in either one of the three following categories:

    • Veterans who undergo PAD - related operations including but not limited to the following:

      • aortobifemoral or aortobiiliac bypass
      • open abdominal aortic aneurysm repair with simultaneous repair of aortoiliac occlusive disease
      • visceral bypass
      • iliofemoral bypass
      • femoral bypass or endarterectomy
      • infrainguinal bypass
      • thromboembolectomy
      • supra-aortic trunk bypass or endarterectomy
      • carotid endarterectomy
      • major lower extremity amputations (transfemoral, through the knee, or transtibial)
    • Veterans with past medical history of ischemic stroke or IHD or PAD who undergo the following general surgery procedures, defined as:

      • known prior MI
      • ECG findings consistent with prior MI
      • prior percutaneous coronary intervention
      • prior coronary artery bypass surgery
      • history of angina for which the patient is currently receiving treatment
      • stress test indicating myocardial ischemia
      • who undergo the following General Surgery operations:

        • Open cholecystectomy or other complex biliary reconstruction
        • such as open common bile duct exploration for stones
        • reconstruction as part of oncologic operations such as palliative pancreatic cancer procedures)
      • small bowel resection
      • pancreatectomy
      • colon resection
      • rectal resection
      • splenectomy
      • transhiatal esophagectomy
      • liver resection
      • gastric resection
      • open ventral hernia repair
      • Colostomies (reversals and takedowns)
    • Veterans with past medical history of ischemic stroke or IHD or PAD who undergo the following Vascular Surgery operations:

      • Open aneurysm repair, including but not limited to:

        • carotid
        • subclavian
        • abdominal aortic
        • iliac
        • femoral
        • popliteal aneurysms
      • and complex endovascular aneurysm repair, defined as:

        • fenestrated endograft
        • or endograft with need for iliac conduit
        • or endovascular aneurysm repair with simultaneous femoral artery reconstruction or bypass
  • Patients undergoing the above procedures will be included in the study regardless of their preoperative Hb level, and regardless of preoperative or intraoperative transfusion they might have received.

Exclusion Criteria:

  • Veteran unable to consent
  • Veteran unwilling to follow protocol (such as Jehovah's witnesses)
  • Veteran with known history of hereditary anemias such as Thalassemia or Sickle cell disease
  • Veteran with known history of hereditary bleeding disorders, such as factor VIII or factor IX deficiency
  • Veteran with prior history of adverse reaction to blood administration, such as fever, rash, or hemolysis
  • Veteran does not speak or understand English
  • Veteran hemodynamically unstable or in cardiogenic shock
  • Veteran participating in another interventional trial whose objective is to evaluate the effect of transfusion on outcomes
  • Pregnancy in female Veterans
  • Veteran is a prisoner or in custody of law enforcement
  • Prior randomization in the CSP#599

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03229941


Contacts
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Contact: Panagiotis Kougias, MD MSc (713) 791-1414 panagiotis.kougias@va.gov
Contact: Sherene Sharath, MPH (713) 794-7700 sherene.sharath@va.gov

Locations
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United States, Arkansas
Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR Recruiting
Little Rock, Arkansas, United States, 72205-5484
Contact: Mohammed Moursi, MD       Mohammed.Moursi@va.gov   
Contact: Alison Acott, MD    5013101735    Alison.Acott@va.gov   
United States, California
VA Loma Linda Healthcare System, Loma Linda, CA Recruiting
Loma Linda, California, United States, 92357
Contact: Christian Bianchi, MD    909-825-7084    Christian.Bianchi@va.gov   
Contact: Stephanie Maroney, MD    9098257084    Stephanie.Maroney@va.gov   
VA Palo Alto Health Care System, Palo Alto, CA Recruiting
Palo Alto, California, United States, 94304-1290
Contact: Shipra Arya, MD    650-493-5000    Shipra.Arya2@va.gov   
Contact: MD         
San Francisco VA Medical Center, San Francisco, CA Recruiting
San Francisco, California, United States, 94121
Contact: Warren Gasper, MD    415-221-4810    Gasper.Warren@va.gov   
Contact: Lygia Stewart, MD    4157506922    Lygia.Stewart@va.gov   
United States, Florida
North Florida/South Georgia Veterans Health System, Gainesville, FL Recruiting
Gainesville, Florida, United States, 32608
Contact: George Sarosi, MD       George.Sarosi@va.gov   
Contact: Salvatori Scali, MD    3525486470    Salvatore.Scali@va.gov   
James A. Haley Veterans' Hospital, Tampa, FL Recruiting
Tampa, Florida, United States, 33612
Contact: James Brooks, MD       James.Brooks@va.gov   
United States, New York
VA Western New York Healthcare System, Buffalo, NY Recruiting
Buffalo, New York, United States, 14215
Contact: Mariel Rivero, MD    215-537-2971    Mariel.Rivero@va.gov   
Contact: Meliton Silva, MD       Meliton.Silva@va.gov   
United States, North Carolina
Asheville VA Medical Center, Asheville, NC Recruiting
Asheville, North Carolina, United States, 28805
Contact: Mark Kadowaki, MD    828-298-7911 ext 3598    Mark.Kadowaki@va.gov   
Contact: Jeffery Nienaber, MD    8282987911    Jeffery.Nienaber@va.gov   
United States, Ohio
Louis Stokes VA Medical Center, Cleveland, OH Recruiting
Cleveland, Ohio, United States, 44106
Contact: Jessie Jean-Claude, MD    216-791-3800 ext 3397    Jessie.Jean2@va.gov   
Contact: Katherine Kelly, MD    2167913800    Katherine.Kelly@va.gov   
United States, Oregon
VA Portland Health Care System, Portland, OR Recruiting
Portland, Oregon, United States, 97239
Contact: Matthew Koopman, MD       Matthew.Koopman@va.gov   
Contact: Mitchell Sally, MD       Mitchell.Sally@va.gov   
United States, Pennsylvania
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA Recruiting
Pittsburgh, Pennsylvania, United States, 15240
Contact: Edith Tzeng, MD    412-360-1657    Edith.Tzeng@va.gov   
Contact: Mark Wilson, MD    4123606102    Mark.Wilson5@va.gov   
United States, Texas
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX Recruiting
Dallas, Texas, United States, 75216
Contact: Thai Pham, MD    214-857-2176    Thai.Pham2@va.gov   
Contact: Bala Ramanan, MD    4027077066    Bala.Ramanan@va.gov   
Michael E. DeBakey VA Medical Center, Houston, TX Recruiting
Houston, Texas, United States, 77030
Contact: Tony Lu, MD    713-794-7521    Tony.Lu2@va.gov   
Contact: Samir Awad, MD    (713) 794-8737    Samir.Awad@va.gov   
Study Chair: Panagiotis Kougias, MD MSc         
United States, Washington
VA Puget Sound Health Care System Seattle Division, Seattle, WA Recruiting
Seattle, Washington, United States, 98108
Contact: Gale Tang, MD    202-764-2245    Gale.Tang@va.gov   
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Study Chair: Panagiotis Kougias, MD MSc Michael E. DeBakey VA Medical Center, Houston, TX
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03229941    
Other Study ID Numbers: 599
First Posted: July 26, 2017    Key Record Dates
Last Update Posted: October 27, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Acute Kidney Injury
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases