NCT00948792

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 29, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
7 months until next milestone

Results Posted

Study results publicly available

July 12, 2011

Completed
Last Updated

July 12, 2011

Status Verified

June 1, 2011

Enrollment Period

1.6 years

First QC Date

July 27, 2009

Results QC Date

February 21, 2011

Last Update Submit

June 13, 2011

Conditions

Thrombocytopenia

Keywords

plateletstransfusionthrombocytopenia

Outcome Measures

Primary Outcomes (3)

  • Change in Post-transfusion Platelet Counts

    The difference between the baseline platelet count and the platelet count taken 30 minutes after completion of the transfusion.

    Baseline-30 minutes after transfusion

  • Change in Post-transfusion Platelet Counts

    The difference between the baseline platelet count and the platelet count taken 6 hours after completion of the transfusion.

    Baseline - 6 hours after transfusion

  • 30 Minute-6 Hour Difference in Platelet Counts

    30 minutes - 6 hours after transfusion

Study Arms (2)

Long transfusion group

ACTIVE COMPARATOR

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.

Procedure: Long platelet transfusion

Short transfusion group

EXPERIMENTAL

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.

Procedure: Short platelet transfusion

Interventions

Short platelet transfusionPROCEDURE

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

Short transfusion group
Long platelet transfusionPROCEDURE

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

Long transfusion group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Infants with significant thrombocytopenia requiring a transfusion of platelets.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (6)

  • 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.

    PMID: 12823341BACKGROUND

  • 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.

    PMID: 19117893BACKGROUND

  • 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.

    PMID: 14977890BACKGROUND

  • 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.

    PMID: 12937037BACKGROUND

  • 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.

    PMID: 18684573BACKGROUND

  • 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.

    PMID: 18194380BACKGROUND

MeSH Terms

Conditions

Thrombocytopenia

Condition Hierarchy (Ancestors)

Blood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopenia

Results Point of Contact

Title
Doug Dannaway
Organization
University of Oklahoma Health Sciences Center
douglas-dannaway@ouhsc.edu
4052715215

Study Officials

  • Douglas Dannaway, M.D.

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 27, 2009

First Posted

July 29, 2009

Study Start

May 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

July 12, 2011

Results First Posted

July 12, 2011

Record last verified: 2011-06

Locations

US(1)