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Protocol Details

Short or Long Infusion Duration for Platelets: The SOLID Platelet Study

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

19-CC-0005

Sponsoring Institute

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: 100

Referral Letter Required

Yes

Population Exclusion(s)

Children

Keywords

Platelet Transfusion Refractoriness;
Continuous Platelet Transfusion

Recruitment Keyword(s)

None

Condition(s)

Platelet Transfusion Refractoriness (PTR);
Thrombocytopenia

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Other: Platelet Transfusion - LONG Platelet Transfusion
Other: Platelet Transfusion - SHORT Platelet Transfusion

Supporting Site

NIH Clinical Center

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.

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Eligibility

INCLUSION CRITERIA:

- Ability to comprehend the investigational nature of the study and provide informed consent

- Thrombocytopenia

--Causes of thrombocytopenia may be due to:

1. Congenital causes

2. Bone marrow

3. Hematologic malignancies

4. Treatment related

--Thrombocytopenia is generally defined as one of the following:

1. <10K/uL without bleeding

2. <20K/uL for "complicated prophylaxis" in patient s determined to be at increased risk of bleeding or other complications

3. <50K/uL with evidence of active bleeding, such as intracranial hemorrhage, GI bleeding, pulmonary hemorrhage, uncontrolled epistaxis, hematuria.

The treating provider may change the platelet transfusion threshold based on the clinical circumstance, patient population, and/or concurrent primary protocol considerations - similar to the PLADO study.

- Diagnosed with PTR, characterized by the following:

-- Lack of adequate post-transfusion platelet count increment, defined by, CCI <5000/ul at 10-60 min after each of at least 2 consecutive platelet transfusions

-- Presence of anti-HLA class 1 type A and/or type B antibody, in the setting of PTR, as defined above, constitutes the HLA alloimmune-mediated subtype of PTR. Presence of one or more HPA antibodies in the setting of PTR, as defined above,constitutes the HPA alloimmune-mediated subtype of PTR. Failure to detect HLA or HPA antibodies will be categorized as non-alloimmune-mediated PTR. .

EXCLUSION CRITERIA:

- Less than 18-years-old

- Lack of ability to obtain informed consent

- Pregnant female

- Presence of ITP/autoimmune thrombocytopenia

- Immune platelet refractoriness responsive to treatment with IVIg or eculizumab, or other immunosuppressive therapy within the 3 preceding months. This is based on the wide variation in the duration therapeutic antibodies, with the upper limit frequently cited as 3 months.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Willy A. Flegel, M.D.
National Institutes of Health Clinical Center (CC)
NIHBC 10 - CLINICAL CENTER BG RM 1C733C
10 CENTER DR
BETHESDA MD 20892
(301) 594-7401
bill.flegel@nih.gov

Sarah Pogue, R.N.
National Institutes of Health Clinical Center (CC)
National Institutes of Health
Building 10
Room 1C711
10 Center Drive
Bethesda, Maryland 20892
(301) 496-9702
sarah.pogue@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT03712618

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