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Phase 1 Safety Study of Dimethyl Sulfoxide Cryopreserved Platelets

Information source: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Thrombocytopenia

Intervention: CPP (Biological); LSP (Biological)

Phase: Phase 1

Status: Recruiting

Sponsored by: U.S. Army Medical Research and Materiel Command

Official(s) and/or principal investigator(s):
Sherrill J Slichter, MD, Principal Investigator, Affiliation: Puget Sound Blood Center
Terry B Gernsheimer, MD, Principal Investigator, Affiliation: University of Washington, Division of Hematology
Zbigniew Szczepiorkowski, MD, PhD, Principal Investigator, Affiliation: Center for Transfusion Medicine Research, Lebanon, NH
Jose A Cancelas-Perez, MD, PhD, Principal Investigator, Affiliation: Hoxworth Blood Center

Overall contact:
Sherrill J Slichter, MD, Phone: 206-292-6541, Email: sjslichter@psbc.org

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.

Clinical Details

Official title: Dose Escalation Study Evaluating the Safety of Dimethyl Sulfoxide Cryopreserved Platelets Compared With Liquid Stored Platelets in Patients With Uncontrolled Bleeding Not Responding to Standard Platelet Therapy

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Number of adverse events

Number thrombotic events

Pre and post CPP transfusion coagulation parameters

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

- 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

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.

Locations and Contacts

Sherrill J Slichter, MD, Phone: 206-292-6541, Email: sjslichter@psbc.org

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire 03756, United States; Not yet recruiting
Larry Dumont, PhD, MBA, Phone: 603-650-5840, Email: Larry.J.Dumont@Hitchcock.org

Hoxworth Blood Center, Cincinnati, Ohio 45267, United States; Not yet recruiting
Jose Cancelas-Perez, MD, PhD, Phone: 513-558-1324, Email: Jose.Cancelas@cchmc.org

Puget Sound Blood Center, Seattle, Washington 98104, United States; Recruiting
Sherrill J Slichter, MD, Phone: 206-292-6541, Email: sjslichter@psbc.org
Sherrill J Slichter, MD, Principal Investigator

University of Washington, Division of Hematology, Seattle, Washington 98195, United States; Recruiting
Terry B Gernsheimer, MD, Phone: 206-543-3360, Email: bldbuddy@u.washington.edu
Terry B Gernsheimer, MD, Principal Investigator

Additional Information

Starting date: August 2014
Last updated: May 20, 2015

Page last updated: August 23, 2015

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