NCT02535208

Combining Restrictive Guidelines and a NIRS SCORE to Decrease RBC Transfusions

Completed NA Last updated 19 October 2018

What this trial tests

NA trial testing Restrictive transfusions based on SCOR assessment in Anemia of Prematurity (AOP) in 10 participants. Completed in 3 October 2018.

Timeline

16 May 2016

Primary endpoint
3 October 2018

3 October 2018

Quick facts

Lead sponsor	NYU Langone Health
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	10
Start date	16 May 2016
Primary completion	3 October 2018
Estimated completion	3 October 2018
Sites	2 locations across United States

Drugs / interventions tested

• Restrictive transfusions based on SCOR assessment
• Liberal transfusions

Conditions studied

• Anemia of Prematurity (AOP) — all drugs for Anemia of Prematurity (AOP) →

Sponsor

NYU Langone Health — full company profile →

Who can join

Under 3 Days, any sex, with Anemia of Prematurity (AOP). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary aim of this study is to determine the mean number of red blood cell (RBC) transfusions received by preterm infants cared for using restrictive Hgb guidelines in combination with splanchnic to cerebral oxygenation ratio (SCOR) assessment compared to the mean number of transfusions received by preterm infants cared for using liberal guidelines alone.

This study is designed as a prospective randomized controlled trial. Preterm infants less than 30 weeks gestational age and 500-1250 grams in weight will be recruited and enrolled into the study during day of life 0 to 3. Study participants will be randomly assigned into two groups: a restrictive transfusion group and a liberal transfusion group. In the liberal group, RBC transfusions will be given to subjects when their Hgb level falls below defined values that are based on respiratory support status. In the restrictive group, RBC transfusions will be given to subjects either when their Hgb level falls below defined values based on respiratory status or, despite not having reached their Hgb trigger threshold, if they manifest symptoms judged by the clinical care team to be consistent with anemia (i.e. apnea, bradycardia, or desaturation episodes) and subsequently have a near-infrared spectroscopy (NIRS) evaluation that demonstrates an SCOR \< 0.73.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Research Opportunities to Improve Neonatal Red Blood Cell Transfusion.
   Patel RM, Meyer EK, Widness JA. · · 2016 · cited 23× · PMID 27424006 · DOI 10.1016/j.tmrv.2016.06.005
2. Epidemiology of Necrotizing Enterocolitis: New Considerations Regarding the Influence of Red Blood Cell Transfusions and Anemia.
   Saroha V, Josephson CD, Patel RM. · · 2019 · cited 20× · PMID 30771812 · DOI 10.1016/j.clp.2018.09.006
3. Restrictive versus liberal red blood cell transfusion strategies for people with haematological malignancies treated with intensive chemotherapy or radiotherapy, or both, with or without haematopoietic stem cell support.
   Radford M, Estcourt LJ, Sirotich E, Pitre T, et al · · 2024 · cited 8× · PMID 38780066 · DOI 10.1002/14651858.cd011305.pub3