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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03712618
The ClinicalTrials.gov registry entry for NCT03712618 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Platelet Transfusion - LONG Platelet Transfusion is the first listed.
NCT03712618 reports 0 study locations.
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.
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