ThrombocytopeniaNCT00948792

Study of the Effect of Differing Platelet Transfusion Times in Neonates

A study testing Short platelet transfusion and Long platelet transfusion in people with Thrombocytopenia, run by University of Oklahoma at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

To evaluate changes in platelet counts and hemodynamics between "rapid" and "long" platelet infusion groups. Read more about this study

Who is it for?: Any age
Conditions the study is for: Thrombocytopenia
What is being tested?: Short platelet transfusion and Long platelet transfusion
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteUnited States
Study dates: May 2009to Dec 2010
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Infants with significant thrombocytopenia requiring a transfusion of platelets.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Children's Hospital of Oklahoma
Oklahoma City, Oklahoma, 73104

Other trials in United States

About this study

Official title: The Effect of Variable Platelet Transfusion Durations on Platelet Count in Thrombocytopenic Newborns

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

Read the detailed description

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.
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: Thrombocytopenia
Being tested: Short platelet transfusion, Long platelet transfusion
Keywords: platelets, transfusion, thrombocytopenia
Medical subject headings: Thrombocytopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Short platelet transfusionProcedure or surgery
15cc/kg of non-centrifuged, non-refrigerated, leukoreduced, AB-negative pheresis platelets administered over 30 minutes
Long platelet transfusionProcedure or surgery
15cc/kg of non-centrifuged, non-refrigerated, leukoreduced, AB-negative pheresis platelets given over two hours.

Study groups in NCT00948792
Study group	Role	What they receive
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. Receives: 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. Receives: Procedure: Short platelet transfusion

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Baseline - 6 hours after transfusion
30 Minute-6 Hour Difference in Platelet Counts
Measured: 30 minutes - 6 hours after transfusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2009Dec 2010

First posted29 Jul 2009 (estimated)
Study startMay 2009
Primary completionDec 2010
Study completionDec 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for ThrombocytopeniaStudies of the same condition, open and under way.
More trials run by University of OklahomaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00948792
Sponsor's protocol ID: 14626
Status last verified: Jun 2011
First submitted: 27 Jul 2009
Last updated: 12 Jul 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 12823341
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.
PubMed 19117893
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.
PubMed 14977890
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.
PubMed 12937037
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.
PubMed 18684573
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.
PubMed 18194380

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
RecruitingPhase 3
rhTPO for Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Procedures.
Thrombocytopenia Associated With Chronic Liver Disease
RecruitingPhase 2
A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)
Primary Immune Thrombocytopenia (ITP), Primary Evans Syndrome (ES)
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingPhase 1/2
A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia
Immune Thrombocytopenia (ITP)

All Thrombocytopenia trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Variable Platelet Transfusion Durations on Platelet Count in Thrombocytopenic Newborns
ClinicalTrials.gov ID: NCT00948792
Acronym / sponsor ID: 14626
Conditions: Thrombocytopenia
Keywords: platelets, transfusion, thrombocytopenia
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: University of OklahomaUniversity, hospital or other
Study start: May 2009
Primary completion: Dec 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 29 Jul 2009 (estimated)
Results: Posted 12 Jul 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

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.
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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Long transfusion group	Active comparator	Procedure: Long platelet transfusionThis 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.
Short transfusion group	Experimental	Procedure: Short platelet transfusionThis 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.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

Infants with significant thrombocytopenia requiring a transfusion of platelets.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Short platelet transfusion15cc/kg of non-centrifuged, non-refrigerated, leukoreduced, AB-negative pheresis platelets administered over 30 minutes	Procedure or surgery	Short transfusion group
Long platelet transfusion15cc/kg of non-centrifuged, non-refrigerated, leukoreduced, AB-negative pheresis platelets given over two hours.	Procedure or surgery	Long transfusion group

Primary outcome

Change in Post-transfusion Platelet Counts
Time frame: Baseline-30 minutes after transfusion
The difference between the baseline platelet count and the platelet count taken 30 minutes after completion of the transfusion.
Change in Post-transfusion Platelet Counts
Time frame: Baseline - 6 hours after transfusion
The difference between the baseline platelet count and the platelet count taken 6 hours after completion of the transfusion.
30 Minute-6 Hour Difference in Platelet Counts
Time frame: 30 minutes - 6 hours after transfusion

Results and safety

Results posted to the registry on 12 Jul 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Short and Long Transfusion Group	21	21

Primary outcome: Change in Post-transfusion Platelet Counts

Time frame: Baseline-30 minutes after transfusion. Median (Full Range). Unit: Platelets (*10^3/mm^3)

Measure	Long Transfusion Group n = 14	Short Transfusion Group n = 15
Value	99 (-19 to 442)	97.5 (19 to 260)

Long Transfusion Group vs Short Transfusion Group: p = 0.8, Wilcoxon (Mann-Whitney)

Population analysed: Transfusions were randomized, not babies. Therefore, each baby could provide transfusions falling into either arm of randomization. The 21 long transfusions were provided by 14 infants; the 22 short transfusions by 15. This explains the perceived discrepancy.

Primary outcome: Change in Post-transfusion Platelet Counts

Time frame: Baseline - 6 hours after transfusion. Median (Full Range). Unit: Platelets (*10^3/mm^3)

Measure	Long Transfusion Group n = 14	Short Transfusion Group n = 15
Value	75 (-17 to 316)	104 (4 to 294)

Long Transfusion Group vs Short Transfusion Group: p = 0.26, Wilcoxon (Mann-Whitney)

Primary outcome: 30 Minute-6 Hour Difference in Platelet Counts

Time frame: 30 minutes - 6 hours after transfusion. Median (Full Range). Unit: Platelets (*10^3/mm^3)

Measure	Long Transfusion Group n = 14	Short Transfusion Group n = 15
Value	-17.5 (-110 to 29)	-3 (-84 to 81)

Long Transfusion Group vs Short Transfusion Group: p = 0.09, Wilcoxon (Mann-Whitney)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Long Transfusion Group	0 of 14 (0%)	0 of 14 (0%)	Not reported
Short Transfusion Group	0 of 15 (0%)	0 of 15 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 12823341British 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.
Background: PubMed 19117893Josephson 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.
Background: PubMed 14977890Murray NA, Roberts IA. Neonatal transfusion practice. Arch Dis Child Fetal Neonatal Ed. 2004 Mar;89(2):F101-7. doi: 10.1136/adc.2002.019760.
Background: PubMed 12937037Roberts 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.
Background: PubMed 18684573Sola-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.
Background: PubMed 18194380Strauss 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.

Related trials for Thrombocytopenia

RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
RecruitingPhase 3
rhTPO for Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Procedures.
Thrombocytopenia Associated With Chronic Liver Disease
RecruitingPhase 2
A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)
Primary Immune Thrombocytopenia (ITP), Primary Evans Syndrome (ES)
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingPhase 1/2
A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia
Immune Thrombocytopenia (ITP)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Douglas Dannaway, M.D. principal investigator

University of Oklahoma

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Short platelet transfusion and Long platelet transfusion in people with Thrombocytopenia, run by University of Oklahoma at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Post-transfusion Platelet Counts (time frame: Baseline-30 minutes after transfusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00948792, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2011.