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| ID | Type | Description | Link |
|---|---|---|---|
| 1U01HL116383-01 | U.S. NIH Grant/Contract | View source | |
| MOP 126113 | Other Grant/Funding Number | Canadian Institutes of Health Research (CIHR) |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| Ministere de la Sante et des Services Sociaux | OTHER |
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ABC PICU is a randomized clinical trial that will compare the clinical consequences of RBC storage duration in 1538 critically ill children. Laboratory and observational evidence points to serious concerns about the lack of safety and effectiveness of older RBCs, especially in more vulnerable populations. Physicians and institutions have been systematically transfusing fresh RBCs to some pediatric patients primarily because of beliefs that the use of fresh RBCs improve outcomes. Conversely, the standard practice of blood banks is to deliver the oldest RBC unit in order to decrease blood wastage. To provide much needed high quality evidence to answer the question "do RBCs of reduced storage duration improve outcomes?" The ABC PICU Trial will conduct a RCT comparing development of New or Progressive Multiple Organ Dysfunction Syndrome (NPMODS) in critically ill children transfused with either RBCs stored ≤ 7 days or standard issue RBCs (expected mean RBC storage duration of 17-21 days).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short storage | Active Comparator | Red blood cells storage duration of equal to or less than 7 days. |
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| Standard issue | Active Comparator | Red blood cells storage duration of 2 to 42 days with an expected average length of storage of about 17-21 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Short storage RBC age | Biological | IND obtained to cover the expiration date on the red blood cell unit |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With New or Progressive Multiple Organ Dysfunction Syndrome (NPMODS) | The primary outcome measure of this RCT is NPMODS defined as the proportion of patients who die during the 28 days after randomization or who develop NPMODS. For patients with no organ dysfunction at randomization, New MODS is the development of ≥ 2 concurrent organ dysfunctions during the 28 days after randomization. For patients with 1 organ dysfunction at randomization, New MODS is the development of at least 1 other concurrent organ dysfunction after randomization. Patients with MODS (ie concurrent dysfunction of ≥ 2 organ systems) at randomization can develop Progressive MODS defined as development of at least 1 additional concurrent organ dysfunction at during the 28 days after randomization. All deaths will be considered Progressive MODS. NPMODS will be monitored up to 28 days or ICU discharge because it is almost never observed beyond this time in children. | 28 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Organ Dysfunction | Difference in number of organ dysfunctions. | Up to 28 days after randomization. |
| PELOD-2 Score | Difference in PELOD-2 score. Change from randomization to Worst PELOD-2 score. (Pediatric Logistic Organ Dysfunction) Points are on a range of 0-6 and based on Neurologic, cardiovascular, renal, respiratory, and hematologic function. The higher the score the worse the organ failure is and higher mortality rate. |
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Patients are considered eligible to participate in the trial if one of the following occur:
First RBC transfusion is requested within the first 7 days (168 hours) of ICU admission.
OR
First RBC transfusion is requested for a patient in the Emergency Room, and the PICU team is involved with the clinical care of the patient, and the patient will definitively be transferred to the ICU.
OR
Patient assessed pre-operatively and for whom ICU admission is planned post-operatively, and who is determined to definitively require a first RBC transfusion during surgery.
Inclusion Criteria:
Eligible critically ill pediatric patients who have an expected length of stay after transfusion in the ICU > 24 hours based on the best judgment of the attending ICU staff.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip C. Spinella, MD | Washington University School of Medicine, St. Louis | Principal Investigator |
| Marisa Tucci, MD | Ste-Justine Hospital, Montreal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35223 | United States | ||
| Diamond Children's Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31821429 | Derived | Spinella PC, Tucci M, Fergusson DA, Lacroix J, Hebert PC, Leteurtre S, Schechtman KB, Doctor A, Berg RA, Bockelmann T, Caro JJ, Chiusolo F, Clayton L, Cholette JM, Guerra GG, Josephson CD, Menon K, Muszynski JA, Nellis ME, Sarpal A, Schafer S, Steiner ME, Turgeon AF; ABC-PICU Investigators, the Canadian Critical Care Trials Group, the Pediatric Acute Lung Injury and Sepsis Investigators Network, the BloodNet Pediatric Critical Care Blood Research Network, and the Groupe Francophone de Reanimation et Urgences P. Effect of Fresh vs Standard-issue Red Blood Cell Transfusions on Multiple Organ Dysfunction Syndrome in Critically Ill Pediatric Patients: A Randomized Clinical Trial. JAMA. 2019 Dec 10;322(22):2179-2190. doi: 10.1001/jama.2019.17478. | |
| 30055634 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Short Storage | Red blood cells storage duration of equal to or less than 7 days. Short storage RBC age: IND obtained to cover the expiration date on the red blood cell unit |
| FG001 | Standard Issue |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 13, 2017 |
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| Up to 28 days after randomization. |
| Nosocomial Infection | Difference in nosocomial infection rate. | Up to 28 days after randomization. |
| Sepsis, Severe Sepsis, Septic Shock | Difference in the rate of sepsis, severe sepsis or septic shock. | Up to 28 days after randomization. |
| Acute Respiratory Distress Syndrome | Difference in the rate of acute respiratory distress syndrome. | Up to 28 days after randomization. |
| Mechanical Ventilation | 28 day mechanical ventilation free days | Up to 28 days after randomization. |
| ICU Free Days | Difference in ICU free days. | Up to 28 days after randomization |
| Mortality | Difference in 90 day mortality. | Up to 90 days after randomization |
| Delirium | Transfusion Associated Delirium in pediatric critically ill children | up to 72 hours post last study transfusion |
| Tucson |
| Arizona |
| 85721 |
| United States |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | United States |
| Children's Hospital of Orange County | Orange | California | 92868 | United States |
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| The Children's Hospital and University of Colorado Denver School of Medicine | Aurora | Colorado | 80045 | United States |
| UF Health Shands Children's Hospital | Gainesville | Florida | United States |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | United States |
| Lutheran General Hospital | Park Ridge | Illinois | United States |
| James Whitcomb Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Weill Cornell Medical College | New York | New York | 10065 | United States |
| Golisano Children's Hospital at Strong | Rochester | New York | 14642 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Children's Medical Center Dallas | Dallas | Texas | 75390 | United States |
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Stollery Children's Hospital | Edmonton | Alberta | T6G 2B7 | Canada |
| IWK Health Centre | Halifax | Nova Scotia | B3K 6R8 | Canada |
| London Health Sciences Centre | London | Ontario | N6A 5W9 | Canada |
| Children's Hospital of Eastern Ontario | Ottawa | Ontario | K1H 8L1 | Canada |
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| CHU Sainte Justine | Montreal | Quebec | H3T 1C5 | Canada |
| Centre Hospitalier de I'Universite Laval | Québec | G1V 4G2 | Canada |
| Hôpital Necker-enfants | Paris | Malades Paris | 75015 | France |
| Place Amélie Raba Léon | Bordeaux | 33076 | France |
| Hôpital Jeanne de Flandre | Lille | 59037 | France |
| Hôpital Mère Enfant | Nantes | 44093 | France |
| Hôpital Robert Debré | Paris | 75019 | France |
| Hôpital Universitaire Necker - Enfants Malades | Paris | 75743 | France |
| CHU Pontchaillou | Rennes | 35033 | France |
| Sheba Medical Center | Tel Litwinsky | Israel |
| Meyer's Hospital | Florence | Italy |
| Bamino Gesú | Rome | 00165 | Italy |
| Derived |
| Tucci M, Lacroix J, Fergusson D, Doctor A, Hebert P, Berg RA, Caro J, Josephson CD, Leteurtre S, Menon K, Schechtman K, Steiner ME, Turgeon AF, Clayton L, Bockelmann T, Spinella PC; Canadian Critical Care Trials Group; Pediatric Critical Care Blood Research Network (BloodNet); Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. The age of blood in pediatric intensive care units (ABC PICU): study protocol for a randomized controlled trial. Trials. 2018 Jul 28;19(1):404. doi: 10.1186/s13063-018-2809-y. |
Red blood cells storage duration of 2 to 42 days with an expected average length of storage of about 17-21 days.
Short storage RBC age: IND obtained to cover the expiration date on the red blood cell unit
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Short Storage | Red blood cells storage duration of equal to or less than 7 days. Short storage RBC age: IND obtained to cover the expiration date on the red blood cell unit |
| BG001 | Standard Issue | Red blood cells storage duration of 2 to 42 days with an expected average length of storage of about 17-21 days. Short storage RBC age: IND obtained to cover the expiration date on the red blood cell unit |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | year |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With New or Progressive Multiple Organ Dysfunction Syndrome (NPMODS) | The primary outcome measure of this RCT is NPMODS defined as the proportion of patients who die during the 28 days after randomization or who develop NPMODS. For patients with no organ dysfunction at randomization, New MODS is the development of ≥ 2 concurrent organ dysfunctions during the 28 days after randomization. For patients with 1 organ dysfunction at randomization, New MODS is the development of at least 1 other concurrent organ dysfunction after randomization. Patients with MODS (ie concurrent dysfunction of ≥ 2 organ systems) at randomization can develop Progressive MODS defined as development of at least 1 additional concurrent organ dysfunction at during the 28 days after randomization. All deaths will be considered Progressive MODS. NPMODS will be monitored up to 28 days or ICU discharge because it is almost never observed beyond this time in children. | Development of organ dysfunction in all participants | Posted | Count of Participants | Participants | 28 days after randomization |
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| Secondary | Organ Dysfunction | Difference in number of organ dysfunctions. | Posted | Count of Participants | Participants | Up to 28 days after randomization. |
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| Secondary | PELOD-2 Score | Difference in PELOD-2 score. Change from randomization to Worst PELOD-2 score. (Pediatric Logistic Organ Dysfunction) Points are on a range of 0-6 and based on Neurologic, cardiovascular, renal, respiratory, and hematologic function. The higher the score the worse the organ failure is and higher mortality rate. | Posted | Mean | Standard Error | score on a scale | Up to 28 days after randomization. |
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| Secondary | Nosocomial Infection | Difference in nosocomial infection rate. | Posted | Count of Participants | Participants | Up to 28 days after randomization. |
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| Secondary | Sepsis, Severe Sepsis, Septic Shock | Difference in the rate of sepsis, severe sepsis or septic shock. | Posted | Count of Participants | Participants | Up to 28 days after randomization. |
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| Secondary | Acute Respiratory Distress Syndrome | Difference in the rate of acute respiratory distress syndrome. | Posted | Count of Participants | Participants | Up to 28 days after randomization. |
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| Secondary | Mechanical Ventilation | 28 day mechanical ventilation free days | Posted | Mean | Inter-Quartile Range | days | Up to 28 days after randomization. |
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| Secondary | ICU Free Days | Difference in ICU free days. | Posted | Median | Inter-Quartile Range | days | Up to 28 days after randomization |
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| Secondary | Mortality | Difference in 90 day mortality. | Posted | Count of Participants | Participants | Up to 90 days after randomization |
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| Secondary | Delirium | Transfusion Associated Delirium in pediatric critically ill children | Posted | Count of Participants | Participants | up to 72 hours post last study transfusion |
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28 days for Adverse Events 90 days for mortality
There is a change in the number of patients evaluated due to being lost to follow up in certain events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Short Storage | Red blood cells storage duration of equal to or less than 7 days. Short storage RBC age: IND obtained to cover the expiration date on the red blood cell unit | 49 | 716 | 80 | 728 | 0 | 728 |
| EG001 | Standard Issue | Red blood cells storage duration of 2 to 42 days with an expected average length of storage of about 17-21 days. Short storage RBC age: IND obtained to cover the expiration date on the red blood cell unit | 45 | 714 | 84 | 733 | 0 | 733 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep Vein Thrombosis | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Hemolytic Transfusion Reaction | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Hyperkalemia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Hypocalemia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Major Allergic Reaction | Immune system disorders | Non-systematic Assessment |
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| Nosocomial Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Transfusion Associated Cardiac Overload | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Philip C. Spinella | Washington University School of Medicine | 3142860858 | pspinella@wustl.edu |
| Dec 20, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| United States |
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| Italy |
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| Israel |
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| France |
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