Transfusion of Prematures Trial



Status:Active, not recruiting
Conditions:Obesity Weight Loss, Women's Studies, Anemia
Therapuetic Areas:Endocrinology, Hematology, Reproductive
Healthy:No
Age Range:Any
Updated:3/13/2019
Start Date:December 2012
End Date:December 2019

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Transfusion of Prematures (TOP) Trial: Does a Liberal Red Blood Cell Transfusion Strategy Improve Neurologically-Intact Survival of Extremely-Low-Birth-Weight Infants as Compared to a Restrictive Strategy?

The objective of the TOP trial is to determine whether higher hemoglobin thresholds for
transfusing ELBW infants resulting in higher hemoglobin levels lead to improvement in the
primary outcome of survival and rates of neurodevelopmental impairment (NDI) at 22-26 months
of age, using standardized assessments by Bayley.

Long-term outcomes of extremely low birth weight (ELBW) preterm infants, those weighing less
than or equal to 1000 g at birth, are poor and pose a major health care burden. Virtually all
of these infants are transfused, but at inconsistent hemoglobin (Hgb) thresholds.

The investigators propose in TOP to randomize infants less than or equal to 1000 g BW and <
29 weeks GA to receive red blood cell (RBC) transfusions according to one of two strategies
of Hgb thresholds, either a high Hgb (liberal transfusion) or a low Hgb (restrictive
transfusion) algorithm. It is currently unknown which transfusion strategy is superior. TOP
is powered to demonstrate which strategy reduces the primary outcome of death or
neurodisability in survivors at 22-26 months.

A secondary study entitled "Effect of Blood Transfusion Practices on Cerebral and Somatic
Oximetry", also known as the NIRS study, will determine differences in cerebral oxygenation
and fractional tissue oxygen extraction with NIRS between high and low hemoglobin threshold
groups during red blood cell transfusions. The investigators also propose to determine
whether abnormal cerebral NIRS measures are a better predictor of NDI than hemoglobin alone
and whether abnormal mesenteric NIRS measures are associated with the development of NEC
within the 48 hours following a transfusion.

Extended follow-up: Subjects will be seen for a follow-up visit at 5-6 years corrected age to
assess neurological and functional outcomes at early school age based on neonatal transfusion
threshold.

Inclusion Criteria:

- Birth weight less than 1000 grams.

- Gestational age at least 22 weeks but less than 29 completed weeks

- Admitted to the NICU within 48 hours of life

Exclusion Criteria:

- Considered nonviable by the attending neonatologist

- Cyanotic congenital heart disease

- Parents opposed to the transfusion of blood

- Parents with hemoglobinopathy or congenital anemia

- In-utero fetal transfusion

- Twin-to-twin transfusion syndrome

- Isoimmune hemolytic disease

- Lack of parental consent

- Severe acute hemorrhage, acute shock, sepsis with coagulopathy, or need for
perioperative transfusion.

- Prior blood transfusion on clinical grounds beyond the first 6 hours of life

- High probability that the family is socially disorganized to the point of being unable
to attend follow-up at 22-26 months.
We found this trial at
20
sites
Providence, Rhode Island 02905
Principal Investigator: Abbot R. Laptook, MD
Phone: 401-274-1122
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Barbara J. Stoll, MD
Phone: 404-727-5905
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Waldemar A. Carlo, MD
Phone: 205-934-4680
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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5323 Harry Hines Blvd
Dallas, Texas 75235
(214) 648-3111
Principal Investigator: Myra Wyckoff, MD
Phone: 214-648-3923
Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
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Dallas, TX
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5050 Anthony Wayne Dr
Detroit, Michigan 48201
(313) 577-2424
Principal Investigator: Seetha Shankaran, MD
Phone: 313-745-1436
Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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Detroit, MI
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3040 East Cornwallis RoadTriangle
Durham, North Carolina 27705
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Durham, NC
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Durham, North Carolina 27710
(919) 684-8111
Principal Investigator: Ronald N. Goldberg, MD
Phone: 919-681-6024
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Durham, NC
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
Principal Investigator: Kathleen A. Kennedy, MD MPH
Phone: 713-500-6708
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Phone: 317-274-4715
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Indianapolis, IN
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
Principal Investigator: Edward F. Bell, MD
Phone: 319-356-4006
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Iowa City, IA
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2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Principal Investigator: William Truog, MD
Phone: 816-234-3592
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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Kansas City, MO
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Los Angeles, California 90095
310-825-4321
Principal Investigator: Uday Devaskar, MD
Phone: 310-825-9314
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Carl T D'Angio, MD
Phone: 585-275-6209
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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Albuquerque, New Mexico 87131
(505) 277-0111
Principal Investigator: Kristi L. Watterberg, MD
Phone: 505-272-0180
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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Cincinnati, Ohio 45267
Principal Investigator: Kurt Schibler, MD
Phone: 513-636-3972
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Cincinnati, OH
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Cleveland, Ohio 44106
Principal Investigator: Michele C. Walsh, MD MS
Phone: 216-844-3387
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Cleveland, OH
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Columbus, Ohio 43205
Principal Investigator: Leif Nelin, MD
Phone: 614-355-6724
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Palo Alto, California 94304
Principal Investigator: Krisa P. Van Meurs, MD
Phone: 650-723-5711
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Philadelphia, Pennsylvania 19104
Principal Investigator: Barbara Schmidt, MD
Phone: 215-590-1653
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Philadelphia, PA
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