Phase 1 Safety Study of Dimethyl Sulfoxide Cryopreserved Platelets

Completed · Phase 1

Conditions studied: Thrombocytopenia

In brief

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.

Key facts

Study ID

NCT02078284

Run by

U.S. Army Medical Research and Development Command

People needed

28

Starts

2014-11-05

Expected to finish

2016-07-17

Last updated by the study team

2021-05-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Hoxworth Blood Center — Cincinnati, Ohio, United States
• Puget Sound Blood Center — Seattle, Washington, United States
• University of Washington, Division of Hematology — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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