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The SOLID Platelet Study

Primary Purpose

Platelet Transfusion Refractoriness (PTR), Thrombocytopenia

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Platelet Transfusion - LONG Platelet Transfusion

Platelet Transfusion - SHORT Platelet Transfusion

About this trial

This is an interventional treatment trial for Platelet Transfusion Refractoriness (PTR) focused on measuring Platelet Transfusion Refractoriness, Continuous Platelet Transfusion

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

National Institutes of Health Clinical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Group A

Group B

Arm Description

Group A: Long Transfusion followed by Short Transfusion in the first block

Group B: Short Transfusion followed by Long Transfusion in the first block

Outcomes

Primary Outcome Measures

Adusted platelet measurement area under the curve (AUC)

To evaluate efficacy of continuous platelet transfusions in overcoming platelet transfusion refractoriness, including HLA-alloimmune-mediated refractoriness, in patients with severe thrombocytopenia.

Secondary Outcome Measures

Impact on bleeding

To characterize the efficacy of continuous platelet infusion on bleeding outcomes, as measured during the peri-transfusion period by daily hemostatic assessments using the World Health Organization (WHO) bleeding scale.

Full Information

NCT ID

NCT03712618

First Posted

October 18, 2018

Last Updated

October 18, 2023

Sponsor

National Institutes of Health Clinical Center (CC)

1. Study Identification

Unique Protocol Identification Number

NCT03712618

Brief Title

The SOLID Platelet Study

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 3, 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 10, 2019 (Actual)

Primary Completion Date

December 31, 2026 (Anticipated)

Study Completion Date

December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Institutes of Health Clinical Center (CC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

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 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 patient s 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Platelet Transfusion Refractoriness (PTR), Thrombocytopenia

Keywords

Platelet Transfusion Refractoriness, Continuous Platelet Transfusion

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Active Comparator

Arm Description

Group A: Long Transfusion followed by Short Transfusion in the first block

Arm Title

Group B

Arm Type

Active Comparator

Arm Description

Group B: Short Transfusion followed by Long Transfusion in the first block

Intervention Type

Other

Intervention Name(s)

Platelet Transfusion - LONG Platelet Transfusion

Intervention Description

Platelets Transfused over 4-HOURS

Intervention Type

Other

Intervention Name(s)

Platelet Transfusion - SHORT Platelet Transfusion

Intervention Description

Platelets Transfused within 60-minutes

Primary Outcome Measure Information:

Title

Adusted platelet measurement area under the curve (AUC)

Description

To evaluate efficacy of continuous platelet transfusions in overcoming platelet transfusion refractoriness, including HLA-alloimmune-mediated refractoriness, in patients with severe thrombocytopenia.

Time Frame

3-years

Secondary Outcome Measure Information:

Title

Impact on bleeding

Description

Time Frame

3-years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

INCLUSION CRITERIA: Ability to comprehend the investigational nature of the study and provide informed consent Thrombocytopenia Causes of thrombocytopenia may be due to: Congenital causes Bone marrow Hematologic malignancies Treatment related Thrombocytopenia is generally defined as one of the following: <10K/uL without bleeding <20K/uL for "complicated prophylaxis" in patient s determined to be at increased risk of bleeding or other complications <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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sarah Pogue, R.N.

Phone

(301) 435-2432

spogue1@mail.nih.gov

First Name & Middle Initial & Last Name or Official Title & Degree

Willy A Flegel, M.D.

Phone

(301) 594-7401

bill.flegel@nih.gov

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Willy A Flegel, M.D.

Organizational Affiliation

National Institutes of Health Clinical Center (CC)

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Institutes of Health Clinical Center

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20892

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

Phone

800-411-1222

Ext

TTY8664111010

prpl@cc.nih.gov

12. IPD Sharing Statement

Links:

URL

https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2019-CC-0005.html

Description

NIH Clinical Center Detailed Web Page

Learn more about this trial

The SOLID Platelet Study

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