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NCT03712618 · ClinicalTrials.gov registry record · Phase 2
The SOLID Platelet Study
A Phase 2 study, sponsored by National Institutes of Health Clinical Center (CC).
- Terminated
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT03712618: Clinical Trial Phase 2 study, sponsored by National Institutes of Health Clinical Center (CC).
NCT03712618 is a Phase 2 study that was terminated before completion, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 2 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03712618, a Phase 2 study, was terminated before completion, sponsored by National Institutes of Health Clinical Center (CC).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study Summary
Background: Platelets are cell fragments in the blood that help it clot. Some people get very low platelet counts during a disease or treatment. Low platelet counts can cause severe bleeding. Some people are not helped by platelet transfusions at the standard transfusion rate. This is called platelet transfusion refractoriness (PTR). Researchers want to learn more about transfusing platelets so they can make transfusions more effective. Objectives: To study the effects of transfusing platelets more slowly than the standard rate. To obtain data to improve the effectiveness of platelet transfusions in people with PTR and decrease the risk of bleeding in some people. Eligibility: Adults ages 18-100 who have very low platelet counts requiring platelet transfusion, and have evidence of PTR Design: Participants will be screened with a review their recent NIH medical records. They will have blood drawn. Participants will have up to three 12-hour treatment blocks. They can have only one block per day. During each block, they will have 2 platelet transfusions in those 12 hours. One transfusion will take place over 1 hour (SHORT infusion). The other will take place over 4 hours (LONG infusion). Participants will be randomly put in 1 of 2 treatment groups. This will dictate whether they get the SHORT or LONG infusion first. Participants will have blood drawn: * When they enroll * Right before each transfusion * 2, 4, and 6 hours after each transfusion Each blood draw will consist of a complete blood count. Smaller tubes that require only small amounts of blood will be used to minimize the amount of blood drawn.
Primary Outcome
The adjusted platelet increment area under the curve (AUC), obtained between 0-hours and 6-hours after start of the platelet transfusion. The AUC (i.e., AUC above the pretransfusion complete blood count (CBC) platelet count, minus the AUC below the pre-transfusion CBC's platelet count) determined by the 0-hour, 2-hour, 4-hour, and 6-hour CBC platelet concentrations, calculated using the trapezoid rule. Adjustment to the measured AUC done for the number of platelets transfused during the two tran
Interventions
- BIOLOGICAL Platelet Transfusion - LONG Platelet Transfusion
- BIOLOGICAL Platelet Transfusion - SHORT Platelet Transfusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2019-06-10 |
| Est. Completion | 2021-07-31 |
| Phase | Phase 2 |
Why NCT03712618 stopped before completion
NCT03712618 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Platelet Transfusion - LONG Platelet Transfusion is the first listed.
NCT03712618 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03712618 about?
NCT03712618 is a clinical study titled "The SOLID Platelet Study". Background: Platelets are cell fragments in the blood that help it clot. Some people get very low platelet counts during a disease or treatment. Low platelet counts can cause severe bleeding. Some people are not helped by platelet transfusions at the standard transfusion rate. This is called platel...
What is the current status of trial NCT03712618?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2019-06-10. Estimated completion is 2021-07-31.
What interventions are being tested in trial NCT03712618?
The interventions under investigation include: Platelet Transfusion - LONG Platelet Transfusion (BIOLOGICAL), Platelet Transfusion - SHORT Platelet Transfusion (BIOLOGICAL).
Who is sponsoring clinical trial NCT03712618?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03712618's enrollment target sits among peer trials
2 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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