Phase 1
N=28
Phase 1 Safety Study of Dimethyl Sulfoxide Cryopreserved Platelets
Thrombocytopenia
Bottom Line
View on ClinicalTrials.gov: NCT02078284 ↗Enrolled (actual)
28
Serious AEs
17.9%
Results posted
May 2021
Primary outcome: Primary: Adverse Events (AEs) by Level of Severity — 8; 18; 6; 21 adverse events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- CPP (Biological); LSP (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- U.S. Army Medical Research and Development Command
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events (AEs) by Level of Severity |
8; 18; 6; 21; 5; 6 | — |
| PRIMARY Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity |
4; 6; 3; 5; 1; 4 | — |
| PRIMARY Number of Subject With Thrombotic Events |
0; 0; 0; 0; 0 | — |
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 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.
Data sourced from ClinicalTrials.gov (NCT02078284). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.