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The SOLID Platelet Study

NCT03712618 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2025-05-09

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

Platelet Transfusion - LONG Platelet Transfusion

Platelets transfused over 4-HOURS

BIOLOGICAL

Platelet Transfusion - SHORT Platelet Transfusion

Platelets transfused over 60-minutes

Sponsors & Collaborators

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

  • Willy A Flegel, M.D. · National Institutes of Health Clinical Center (CC)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-10
Primary Completion
2021-07-31
Completion
2021-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03712618 on ClinicalTrials.gov