Phase 1 Safety Study of Dimethyl Sulfoxide Cryopreserved Platelets

Therapuetic Areas:Hematology
Age Range:18 - Any
Start Date:November 5, 2014
End Date:July 17, 2016

Use our guide to learn which trials are right for you!

Dose Escalation Study Evaluating the Safety of Dimethyl Sulfoxide Cryopreserved Platelets Compared With Liquid Stored Platelets in Patients With Uncontrolled Bleeding

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.

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.

- LSP transfusion within the previous 48 hours.

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

- 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.
We found this trial at
1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Phone: 603-650-5840
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
Lebanon, NH
Click here to add this to my saved trials
Cincinnati, Ohio 45267
Phone: 513-558-1324
Cincinnati, OH
Click here to add this to my saved trials
Seattle, Washington 98104
Principal Investigator: Sherrill J Slichter, MD
Phone: 206-292-6541
Seattle, WA
Click here to add this to my saved trials
Seattle, Washington 98195
Principal Investigator: Terry B Gernsheimer, MD
Phone: 206-543-3360
Seattle, WA
Click here to add this to my saved trials