NCT06824727

Collection of Peripheral Blood From Patients With Hematologic Malignancies With Thrombocytopenia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 88 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
OTHER	Baseline cell blood counts	Obtain one peripheral blood sample from participants who have severe thrombocytopenia defined as 30,000 platelets/mcl or less

Timeline

• Start date: 2025-01-06
• Primary completion: 2025-08-21
• Completion: 2025-08-21
• First posted: 2025-02-13
• Last updated: 2025-09-05

Locations

1 site across 1 country: United States