Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT03712618
Status:
TERMINATED
Last Update Posted:
2025-05-09
First Post:
2018-10-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The SOLID Platelet Study
Sponsor:
National Institutes of Health Clinical Center (CC)
Organization:
Study Overview
Official Title:
Short or Long Infusion Duration for Platelets: The SOLID Platelet Study
Status:
TERMINATED
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to recruitment difficulty
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
Platelet transfusion can be a life-saving procedure in preventing or treating serious bleeding in patients who have low and/or dysfunctional platelets. Treatment of blood cancer and other blood diseases, as well as bone marrow transplantation, is not possible without platelet transfusion support. Unfortunately, 15- 25% of chronically transfused patients platelet counts will stop responding to these transfusions, putting them at risk for serious bleeding complications. The development of human leukocyte antigen (HLA) antibodies is responsible for 4- 8% of this platelet transfusion refractoriness. The presence of HLA antibodies is a clinical complication that is generally managed by the selection of products that are negative for the antigens for which the patient has antibodies. Often, for patients with chronic and ongoing need, this selection is facilitated by targeted recruitment of donors with known HLA types (i.e., types that lack antigens cognate to the patients known antibodies and are thus predicted to be compatible). However, for very broadly HLA- alloimmunized patients, compatible products may be exceedingly scarce or completely unavailable, precluding the ability to consistently provide products the patient will likely increment from. This research protocol is designed to evaluate the efficacy of a 4-hour continuous infusion of single donor, apheresis platelets in overcoming both alloimmune-mediated and non-alloimmune-mediated platelet refractoriness. We hypothesize that when we transfuse patients over a long duration, who have platelet refractoriness, the platelet counts will increase to higher numbers for an extended period of time in the peri-transfusion period when compared to shorter transfusion intervals.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 19-CC-0005 | None | None | View |