Phase 1 Safety Study of Dimethyl Sulfoxide Cryopreserved Platelets
Condition: Thrombocytopenia
MeSH terms: Thrombocytopenia
Intervention: CPP; LSP
Intervention description: One unit of frozen CPP contains approximately 3.4 x 10^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C.
Intervention MeSH terms: Dimethyl Sulfoxide
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: platelet transfusion

Summary:

      This study is to evaluate the safety of intravenous (IV) infusion of dimethyl sulfoxide
      (DMSO) cryopreserved platelets (CPP) in participants with World Health Organization (WHO)
      Grade 2 bleed in spite of receiving a transfusion of liquid stored platelets (LSP) in the
      past 48 hours by collecting adverse events (AEs) and by evaluating coagulation-related
      parameters to assess the evidence of any thrombotic events after CPP or LSP transfusion.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, at least 18 years of age.

          -  Ability to comprehend the study procedures and signed informed consent.

          -  If pre-menopausal female, must have a negative serum pregnancy test, and, if of child
             bearing potential, must be using an acceptable method of contraception.

          -  Diagnosed with any the following: acute leukemia (ALL or AML), chronic leukemia (CML,
             CLL, CMML, or hairy cell leukemia), myelodysplasia, aplasia, hematopoietic or
             non-hematopoietic solid tumor, or therapy (chemotherapy or radiation) induced bone
             marrow aplasia or hypoplasia. Either autologous or allogeneic bone marrow transplant
             or peripheral or cord blood stem cell recipients may be enrolled.

          -  WHO grade 2 or greater bleeding.

        Exclusion Criteria:

          -  Acute or chronic DIC as evidence by D-dimer greater than 8 μg/mL and fibrinogen less
             than 100 mg (0.1 g)/dL. Both criteria must be met. If data are in the medical record
             for fibrin degradation products (FDPs), then FDP must be <=40 μg/mL (FDP >40 μg/mL is
             indicative of DIC).

          -  PT or aPTT > 1.3 times the upper limit of normal for the laboratory.

          -  History of major operative procedures that required general anesthesia in the past 2
             weeks.

          -  History of any prior major unprovoked thrombotic events and/or known inherited
             disorder of coagulation or platelet function (by history) (not to include clots in
             catheters, etc).

          -  A history or diagnosis of immune thrombocytopenia, thrombotic thrombocytopenic
             purpura, or hemolytic uremic syndrome.

          -  Females who are breastfeeding.

          -  Veno-occlusive disease or possible veno-occlusive disease.

          -  Receiving active, inpatient treatment with anti-platelet drugs and/or full
             anticoagulation therapy. Note: a heparin flush may be given daily and before and after
             blood draws to patients with a central line to keep the line patent.

          -  Subject previously enrolled in this study and received a study transfusion.