ThrombocytopeniaNCT06824727
Collection of Peripheral Blood From Patients With Hematologic Malignancies With Thrombocytopenia
An observational study of Thrombocytopenia, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of the research project is to collect one blood sample from participants who are affected by very low platelets as a result of their condition or their treatment. Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Thrombocytopenia
- What is being tested?
- Baseline cell blood counts
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2025to 21 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Samples will be collected from participants from the bone marrow transplant inpatient service and outpatient clinics.
Who may be able to join
- Adults 18 years or older
- Platelet counts of 30,000/mcl or less
Who cannot join
- Chemotherapy within the last 24 hours from the planned blood sample draw for research purposes.
- Use of anticoagulant agents in the last 48 hours.
- Active infection (i.e. one that has received less than 48 hours of active treatment).
- Adults 89 years or older
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Comprehensive Cancer Center, Cleveland Clinic Foundation Taussig Cancer Institute
Cleveland, Ohio, 44195
About this study
The purpose of the research project is to collect one blood sample from participants who are affected by very low platelets as a result of their condition or their treatment.
Read the detailed description
Thrombocytopenia, a condition characterized by abnormally low platelet counts, is a major complication for patients undergoing stem cell transplantation (SCT) as well as patients treated with high doses of chemotherapy for hematologic malignancies1
. Stem cell transplant is a potentially curative treatment for various blood cancers and other lifethreatening diseases. However, the conditioning regimens used before SCT, typically involving high-dose chemotherapy and/or radiation therapy, often damage the bone marrow, leading to a temporary but profound drop in platelet production. Consequences of Thrombocytopenia in SCT patients and those treated with intense chemotherapy for hematologic malignancies.
- Increased Bleeding Risk: Platelets are essential for blood clotting, and thrombocytopenia significantly increases the risk of bleeding, both minor and potentially life-threatening. This can occur anywhere in the body, including the gastrointestinal tract, lungs, and brain
- Extended Hospital Stays: Bleeding complications often require transfusions of donor platelets, which can be scarce and carry risks of transfusion reactions and infections. This can lead to prolonged hospital stays and delays in engraftment (recovery of normal blood cell production).
Current Management of Thrombocytopenia in SCT:
- Prophylactic Platelet Transfusions: To prevent bleeding, patients often receive prophylactic platelet transfusions, even if they have no symptoms. However, this approach carries risks of transfusion reactions and can strain the blood supply2
- Thrombopoietin-Stimulating Agents (TSAs): These medications stimulate the bone marrow to produce more platelets, but their effectiveness is limited and they may not be suitable for all patients3
The current protocol is aimed at testing a nanoparticle - based product that could act hemostatically as a platelet replacement. This could have several benefits.
- Addressing Platelet Shortage: The development of safe and effective off the shelf platelet replacement could address the shortage of donor platelets and reduce the reliance on donors and transfusions.
- Targeted and Controlled Platelet Function: Specific dosing studies could help understand doses of platelet replacement products for treatment of bleeding as well as the doses and concentrations required for achieve hemostasis and prevent bleeding.
- Reduced Transfusion-Related Risks: Avoiding frequent transfusions would eliminate the risk of transfusion reactions and infections, leading to improved patient safety and outcomes
This protocol is aimed at obtaining one peripheral blood sample from patients who have severe thrombocytopenia defined as 30,000 platelets/mcl or less, so that the effects of a platelet replacement product can be tested in vitro by Haima Therapeutics. This research cannot be done on samples that have been stored or frozen, as these conditions negatively impact remaining platelet function, altering the baseline of the experiments.
- Conditions
- Thrombocytopenia
- Being tested
- Baseline cell blood counts
- Keywords
- Stem Cell Transplant
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline cell blood countsOther
Obtain one peripheral blood sample from participants who have severe thrombocytopenia defined as 30,000 platelets/mcl or less
| Study group | Role | What they receive |
|---|---|---|
| Sample Collection | Not described Receives: Other: Baseline cell blood counts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sample collection of peripheral blood from patients experiencing thrombocytopenia
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start6 Jan 2025
- Primary completion21 Aug 2025
- Study completion21 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Paolo Caimi, MD, Principal investigator, Case Comprehensive Cancer Center, Cleveland Clinic Taussig Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06824727
- Sponsor's protocol ID
- CASE2424
- Other IDs
- 2R44HL145948-02
- Status last verified
- Sep 2025
- First submitted
- 12 Feb 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Peripheral Blood From Patients With Hematologic Malignancies With Thrombocytopenia
- ClinicalTrials.gov ID
- NCT06824727
- Acronym / sponsor ID
- CASE2424
- Conditions
- Thrombocytopenia
- Keywords
- Stem Cell Transplant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 21 Aug 2025 (actual)
- Study completion
- 21 Aug 2025 (actual)
- First posted
- 13 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the research project is to collect one blood sample from participants who are affected by very low platelets as a result of their condition or their treatment.
Detailed description
Thrombocytopenia, a condition characterized by abnormally low platelet counts, is a major complication for patients undergoing stem cell transplantation (SCT) as well as patients treated with high doses of chemotherapy for hematologic malignancies1
. Stem cell transplant is a potentially curative treatment for various blood cancers and other lifethreatening diseases. However, the conditioning regimens used before SCT, typically involving high-dose chemotherapy and/or radiation therapy, often damage the bone marrow, leading to a temporary but profound drop in platelet production. Consequences of Thrombocytopenia in SCT patients and those treated with intense chemotherapy for hematologic malignancies.
- Increased Bleeding Risk: Platelets are essential for blood clotting, and thrombocytopenia significantly increases the risk of bleeding, both minor and potentially life-threatening. This can occur anywhere in the body, including the gastrointestinal tract, lungs, and brain
- Extended Hospital Stays: Bleeding complications often require transfusions of donor platelets, which can be scarce and carry risks of transfusion reactions and infections. This can lead to prolonged hospital stays and delays in engraftment (recovery of normal blood cell production).
Current Management of Thrombocytopenia in SCT:
- Prophylactic Platelet Transfusions: To prevent bleeding, patients often receive prophylactic platelet transfusions, even if they have no symptoms. However, this approach carries risks of transfusion reactions and can strain the blood supply2
- Thrombopoietin-Stimulating Agents (TSAs): These medications stimulate the bone marrow to produce more platelets, but their effectiveness is limited and they may not be suitable for all patients3
The current protocol is aimed at testing a nanoparticle - based product that could act hemostatically as a platelet replacement. This could have several benefits.
- Addressing Platelet Shortage: The development of safe and effective off the shelf platelet replacement could address the shortage of donor platelets and reduce the reliance on donors and transfusions.
- Targeted and Controlled Platelet Function: Specific dosing studies could help understand doses of platelet replacement products for treatment of bleeding as well as the doses and concentrations required for achieve hemostasis and prevent bleeding.
- Reduced Transfusion-Related Risks: Avoiding frequent transfusions would eliminate the risk of transfusion reactions and infections, leading to improved patient safety and outcomes
This protocol is aimed at obtaining one peripheral blood sample from patients who have severe thrombocytopenia defined as 30,000 platelets/mcl or less, so that the effects of a platelet replacement product can be tested in vitro by Haima Therapeutics. This research cannot be done on samples that have been stored or frozen, as these conditions negatively impact remaining platelet function, altering the baseline of the experiments.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sample Collection | – | Other: Baseline cell blood counts |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Samples will be collected from participants from the bone marrow transplant inpatient service and outpatient clinics.
Key inclusion criteria (2 listed)
- Adults 18 years or older
- Platelet counts of 30,000/mcl or less
Key exclusion criteria (4 listed)
- Chemotherapy within the last 24 hours from the planned blood sample draw for research purposes.
- Use of anticoagulant agents in the last 48 hours.
- Active infection (i.e. one that has received less than 48 hours of active treatment).
- Adults 89 years or older
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baseline cell blood countsObtain one peripheral blood sample from participants who have severe thrombocytopenia defined as 30,000 platelets/mcl or less | Other | Sample Collection |
Primary outcome
Sample collection of peripheral blood from patients experiencing thrombocytopenia
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Thrombocytopenia
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
RecruitingPhase 3
rhTPO for Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Procedures.
Thrombocytopenia Associated With Chronic Liver Disease
RecruitingPhase 2
A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)
Primary Immune Thrombocytopenia (ITP), Primary Evans Syndrome (ES)
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingPhase 1/2
A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia
Immune Thrombocytopenia (ITP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo Caimi, MD principal investigator
Case Comprehensive Cancer Center, Cleveland Clinic Taussig Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombocytopenia, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sample collection of peripheral blood from patients experiencing thrombocytopenia (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.