Study of the Effect of Differing Platelet Transfusion Times in Neonates

NCT ID: NCT00948792

Last Updated: 2011-07-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To evaluate changes in platelet counts and hemodynamics between "rapid" and "long" platelet infusion groups.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

1. It is our hypothesis that the change in post-transfusion platelet counts of babies who receive platelets over 30 minutes (short transfusion group) will be significantly different from the change in babies who receive platelets over two hours (long transfusion group) when platelets are checked immediately after transfusion and 6 hours after the completion of transfusion.
2. We also expect there to be significant differences in the platelet counts drawn thirty minutes after transfusion compared to the counts drawn 6 hours after the completion of the transfusion in either group.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Thrombocytopenia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Long transfusion group

This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of two hours.

Group Type ACTIVE_COMPARATOR

Long platelet transfusion

Intervention Type PROCEDURE

15cc/kg of non-centrifuged, non-refrigerated, leukoreduced, AB-negative pheresis platelets given over two hours.

Short transfusion group

This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes.

Group Type EXPERIMENTAL

Short platelet transfusion

Intervention Type PROCEDURE

15cc/kg of non-centrifuged, non-refrigerated, leukoreduced, AB-negative pheresis platelets administered over 30 minutes

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Short platelet transfusion

15cc/kg of non-centrifuged, non-refrigerated, leukoreduced, AB-negative pheresis platelets administered over 30 minutes

Intervention Type PROCEDURE

Long platelet transfusion

15cc/kg of non-centrifuged, non-refrigerated, leukoreduced, AB-negative pheresis platelets given over two hours.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Infants with significant thrombocytopenia requiring a transfusion of platelets.

Exclusion Criteria

* Infants requiring extracorporeal membranous oxygenation.
* Infants with congenital heart disease (other than patent foramen ovale or patent ductus arteriosus).
* Babies diagnosed with neonatal alloimmune thrombocytopenia.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Oklahoma

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

University of Oklahoma Health Sciences Center

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Douglas Dannaway, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Children's Hospital of Oklahoma

Oklahoma City, Oklahoma, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

British Committee for Standards in Haematology, Blood Transfusion Task Force. Guidelines for the use of platelet transfusions. Br J Haematol. 2003 Jul;122(1):10-23. doi: 10.1046/j.1365-2141.2003.04468.x. No abstract available.

Reference Type BACKGROUND
PMID: 12823341 (View on PubMed)

Josephson CD, Su LL, Christensen RD, Hillyer CD, Castillejo MI, Emory MR, Lin Y, Hume H, Easley K, Poterjoy B, Sola-Visner M. Platelet transfusion practices among neonatologists in the United States and Canada: results of a survey. Pediatrics. 2009 Jan;123(1):278-85. doi: 10.1542/peds.2007-2850.

Reference Type BACKGROUND
PMID: 19117893 (View on PubMed)

Murray NA, Roberts IA. Neonatal transfusion practice. Arch Dis Child Fetal Neonatal Ed. 2004 Mar;89(2):F101-7. doi: 10.1136/adc.2002.019760.

Reference Type BACKGROUND
PMID: 14977890 (View on PubMed)

Roberts I, Murray NA. Neonatal thrombocytopenia: causes and management. Arch Dis Child Fetal Neonatal Ed. 2003 Sep;88(5):F359-64. doi: 10.1136/fn.88.5.f359.

Reference Type BACKGROUND
PMID: 12937037 (View on PubMed)

Sola-Visner M, Saxonhouse MA, Brown RE. Neonatal thrombocytopenia: what we do and don't know. Early Hum Dev. 2008 Aug;84(8):499-506. doi: 10.1016/j.earlhumdev.2008.06.004. Epub 2008 Aug 5.

Reference Type BACKGROUND
PMID: 18684573 (View on PubMed)

Strauss RG. How I transfuse red blood cells and platelets to infants with the anemia and thrombocytopenia of prematurity. Transfusion. 2008 Feb;48(2):209-17. doi: 10.1111/j.1537-2995.2007.01592.x. Epub 2008 Jan 7.

Reference Type BACKGROUND
PMID: 18194380 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

14626

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cold Apheresis Platelets in PAS
NCT02754414 UNKNOWN PHASE1
Tranexamic Acid Effect in Pediatric
NCT06097611 NOT_YET_RECRUITING EARLY_PHASE1
Delayed Cold-Stored Platelets -PLTS-1
NCT06147531 RECRUITING PHASE2
Function of Platelets Used for Transfusions
NCT05038722 ENROLLING_BY_INVITATION