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Blood Product

Slow vs Standard Platelet Transfusion for Low Platelet Count

Phase 2
Recruiting
Led By Willy A Flegel, M.D.
Research Sponsored by National Institutes of Health Clinical Center (CC)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Thrombocytopenia
Be older than 18 years old
Must not have
Lack of ability to obtain informed consent
Presence of ITP/autoimmune thrombocytopenia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether transfusing platelets more slowly than the standard rate can be more effective for people with PTR. Blood will be drawn before and after transfusions to study the effects.

Who is the study for?
Adults aged 18-100 with very low platelet counts who need a transfusion and have platelet transfusion refractoriness (PTR), meaning standard transfusions don't increase their platelet count enough. They must understand the study and agree to participate. Excluded are those responsive to certain immune therapies, under 18, unable to consent, with autoimmune thrombocytopenia or pregnant women.
What is being tested?
The trial is testing if giving platelets more slowly than usual can help people whose bodies don't respond well to normal transfusions. Participants will receive two types of transfusions: one over an hour (SHORT) and another over four hours (LONG). They'll be randomly assigned an order for these treatments.
What are the potential side effects?
Potential side effects from the different rates of platelet transfusion aren't specified in detail but may include reactions similar to regular blood product transfusions such as fever, allergic reactions, or infection at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a low platelet count.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am unable to understand or sign the consent form.
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I have ITP or autoimmune-related low platelet count.
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I am under 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adusted platelet measurement area under the curve (AUC)
Secondary study objectives
Impact on bleeding

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Group AActive Control2 Interventions
Group A: Long Transfusion followed by Short Transfusion in the first block
Group II: Group BActive Control2 Interventions
Group B: Short Transfusion followed by Long Transfusion in the first block

Find a Location

Who is running the clinical trial?

National Institutes of Health Clinical Center (CC)Lead Sponsor
389 Previous Clinical Trials
30,879,706 Total Patients Enrolled
Willy A Flegel, M.D.Principal InvestigatorNational Institutes of Health Clinical Center (CC)
2 Previous Clinical Trials
163 Total Patients Enrolled

Media Library

Platelet Transfusion - LONG Platelet Transfusion (Blood Product) Clinical Trial Eligibility Overview. Trial Name: NCT03712618 — Phase 2
Acquired Thrombocytopenia Research Study Groups: Group A, Group B
Acquired Thrombocytopenia Clinical Trial 2023: Platelet Transfusion - LONG Platelet Transfusion Highlights & Side Effects. Trial Name: NCT03712618 — Phase 2
Platelet Transfusion - LONG Platelet Transfusion (Blood Product) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03712618 — Phase 2
~8 spots leftby Dec 2026
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