ThrombocytopeniaPhase 1NCT02078284

Phase 1 Safety Study of Dimethyl Sulfoxide Cryopreserved Platelets

A Phase 1 study testing CPP and LSP in people with Thrombocytopenia, run by U.S. Army Medical Research and Development Command at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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)… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Thrombocytopenia
What is being tested?: CPP and LSP
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 4 sitesUnited States
Study dates: 5 Nov 2014to 17 Jul 2016
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 9Show fewer

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.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Hoxworth Blood Center
Cincinnati, Ohio, 45267
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Puget Sound Blood Center
Seattle, Washington, 98104
University of Washington, Division of Hematology
Seattle, Washington, 98195

Other trials in United States

About this study

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

Read the detailed description

After determining eligibility for study participation, 4 sequential cohorts of subjects will receive escalating doses of CPP (Test) or 1 unit of LSP (Control) randomized 6:1 within each cohort. Each sequential cohort will receive the following transfusions starting with the first cohort: 0.5, 1, 2, and 3 units of CPP with an additional single subject in each cohort who will receive 1 unit of LSP for a total of 28 subjects. Assignment to Test and Control platelets for subjects in each cohort will be centrally randomized using an interactive web response system (IWRS). Following the study transfusion, subjects are followed for evidence of transfusion reactions, thrombotic events, other AEs, coagulation-related parameters, and platelet efficacy endpoints. CPP or LSP will be transfused into a patient according to the randomized product and dose assignment within the cohort. Following the transfusion, subjects are followed for the remainder of Study Day 1 and on Study Day 2 for AEs and tested for coagulation markers including fibrinogen, D-dimer, prothrombin fragments 1 + 2 (F 1+2), thrombin antithrombin (TAT), anti-thrombin (AT), prothrombin time (PT), activated partial thromboplastin time (aPTT), thrombin generation testing (TGT) results, thromboelastography (TEG) results, and other potential complications of platelet transfusion such as transfusion reactions and thrombotic events including assessment of vital signs (blood pressure, heart rate, respiration rate, and pulse oximetry). A subject is considered to have completed the study for safety evaluation for dose escalation, if he/she receives a study infusion and completed study-related Day 3 procedures.

Conditions: Thrombocytopenia
Being tested: CPP, LSP
Keywords: platelet transfusion
Medical subject headings: Thrombocytopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CPPBiological
Also called dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)
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.
LSPBiological
Also called liquid stored platelets (LSP)

Study groups in NCT02078284
Study group	Role	What they receive
Cohort 1 with 0.5 units of CPP	Experimental	A single 30 to 60 minute intravenous (IV) infusion of 0.5 unit of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP) Receives: Biological: CPP
Cohort 1 with 1 unit of LSP	Active comparator	A single 30 to 60 minute intravenous (IV) infusion of 1 unit of liquid stored platelets (LSP) Receives: Biological: LSP
Cohort 2 with 1 unit of CPP	Experimental	A single 30 to 60 minute intravenous (IV) infusion of 1 unit of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP) Receives: Biological: CPP
Cohort 2 with 1 unit of LSP	Active comparator	A single 30 to 60 minute intravenous (IV) infusion of 1 unit of liquid stored platelets (LSP) Receives: Biological: LSP
Cohort 3 with 2 units of CPP	Experimental	A single 30 to 60 minute intravenous (IV) infusion of 2 units of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP) Receives: Biological: CPP
Cohort 3 with 1 unit of LSP	Active comparator	A single 30 to 60 minute intravenous (IV) infusion of 1 unit of liquid stored platelets (LSP) Receives: Biological: LSP
Cohort 4 with 3 units of CPP	Experimental	A single 30 to 60 minute intravenous (IV) infusion of 3 units of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP) Receives: Biological: CPP
Cohort 4 with 1 unit of LSP	Active comparator	A single 30 to 60 minute intravenous (IV) infusion of 1 unit of liquid stored platelets (LSP Receives: Biological: LSP

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse Events (AEs) by Level of Severity
Clinical laboratory [chemistry (serum creatinine, lactate dehydrogenase (LDH), and troponin, and hematology (hemoglobin and hematocrit)] parameters, physical examination findings, electrocardiogram (ECG)] and vital sign AEs summarized by severity.
Measured: day of thru 6 days after transfusion
Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity
Number of subjects who experienced AEs at specific levels of severity. Clinical laboratory [chemistry (serum creatinine, lactate dehydrogenase (LDH), and troponin, and hematology (hemoglobin and hematocrit)] parameters, physical examination findings, electrocardiogram (ECG)] and vital signs were evaluated.
Measured: day of thru 6 days after transfusion
Number of Subject With Thrombotic Events
Subjects with any signs or symptoms of thrombotic events.
Measured: 6 days after transfusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Nov 201417 Jul 2016

First posted5 Mar 2014 (estimated)
Study start5 Nov 2014
Primary completionJul 2016
Study completion17 Jul 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for ThrombocytopeniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02078284
Sponsor's protocol ID: S-12-04
Other IDs: CPP1-05
Status last verified: May 2021
First submitted: 26 Feb 2014
Last updated: 20 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Slichter SJ, Dumont LJ, Cancelas JA, Jones M, Gernsheimer TB, Szczepiorkowski ZM, Dunbar NM, Prakash G, Medlin S, Rugg N, Kinne B, Macdonald VW, Housler G, Valiyaveettil M, Hmel P, Ransom JH. Safety and efficacy of cryopreserved platelets in bleeding patients with thrombocytopenia. Transfusion. 2018 Sep;58(9):2129-2138. doi: 10.1111/trf.14780.
PubMed 30204953

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Enrolling by invitationObservational study
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All Thrombocytopenia trials

Study at a glance

From the registry record, last updated by the sponsor on 20 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dose Escalation Study Evaluating the Safety of Dimethyl Sulfoxide Cryopreserved Platelets Compared With Liquid Stored Platelets in Patients With Uncontrolled Bleeding
ClinicalTrials.gov ID: NCT02078284
Acronym / sponsor ID: S-12-04
Conditions: Thrombocytopenia
Keywords: platelet transfusion
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: U.S. Army Medical Research and Development CommandUS federal agency
Study start: 5 Nov 2014 (actual)
Primary completion: Jul 2016 (actual)
Study completion: 17 Jul 2016 (actual)
First posted: 5 Mar 2014 (estimated)
Results: Posted 20 May 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 8

Arm	Type	Receives
Cohort 1 with 0.5 units of CPP	Experimental	Biological: CPPA single 30 to 60 minute intravenous (IV) infusion of 0.5 unit of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)
Cohort 1 with 1 unit of LSP	Active comparator	Biological: LSPA single 30 to 60 minute intravenous (IV) infusion of 1 unit of liquid stored platelets (LSP)
Cohort 2 with 1 unit of CPP	Experimental	Biological: CPPA single 30 to 60 minute intravenous (IV) infusion of 1 unit of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)
Cohort 2 with 1 unit of LSP	Active comparator	Biological: LSPA single 30 to 60 minute intravenous (IV) infusion of 1 unit of liquid stored platelets (LSP)
Cohort 3 with 2 units of CPP	Experimental	Biological: CPPA single 30 to 60 minute intravenous (IV) infusion of 2 units of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)
Cohort 3 with 1 unit of LSP	Active comparator	Biological: LSPA single 30 to 60 minute intravenous (IV) infusion of 1 unit of liquid stored platelets (LSP)
Cohort 4 with 3 units of CPP	Experimental	Biological: CPPA single 30 to 60 minute intravenous (IV) infusion of 3 units of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)
Cohort 4 with 1 unit of LSP	Active comparator	Biological: LSPA single 30 to 60 minute intravenous (IV) infusion of 1 unit of liquid stored platelets (LSP

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (9 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CPPAlso: dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)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.	Biological	Cohort 1 with 0.5 units of CPP, Cohort 2 with 1 unit of CPP, Cohort 3 with 2 units of CPP, Cohort 4 with 3 units of CPP
LSPAlso: liquid stored platelets (LSP)	Biological	Cohort 1 with 1 unit of LSP, Cohort 2 with 1 unit of LSP, Cohort 3 with 1 unit of LSP, Cohort 4 with 1 unit of LSP

Primary outcome

Adverse Events (AEs) by Level of Severity
Time frame: day of thru 6 days after transfusion
Clinical laboratory [chemistry (serum creatinine, lactate dehydrogenase (LDH), and troponin, and hematology (hemoglobin and hematocrit)] parameters, physical examination findings, electrocardiogram (ECG)] and vital sign AEs summarized by severity.
Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity
Time frame: day of thru 6 days after transfusion
Number of subjects who experienced AEs at specific levels of severity. Clinical laboratory [chemistry (serum creatinine, lactate dehydrogenase (LDH), and troponin, and hematology (hemoglobin and hematocrit)] parameters, physical examination findings, electrocardiogram (ECG)] and vital signs were evaluated.
Number of Subject With Thrombotic Events
Time frame: 6 days after transfusion
Subjects with any signs or symptoms of thrombotic events.

Results and safety

Results posted to the registry on 20 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1 With 0.5 Units of CPP	5	5
Cohort 2 With 1 Unit of CPP	7	7
Cohort 3 With 2 Units of CPP	6	6
Cohort 4 With 3 Units of CPP	6	6
1 Unit of LSP	4	4

Primary outcome: Adverse Events (AEs) by Level of Severity

Time frame: day of thru 6 days after transfusion. Number. Unit: adverse events

Measure	Cohort 1 With 0.5 Units of CPP n = 5	Cohort 2 With 1 Unit of CPP n = 7	Cohort 3 With 2 Units of CPP n = 6	Cohort 4 With 3 Units of CPP n = 6	1 Unit of LSP n = 4
Total number of AEs	8	18	6	21	5
Total mild AEs	6	11	1	9	5
Total moderate AEs	1	3	5	5	0
Total Severe AEs	0	1	0	1	0
Total Life-threatening or Fatal AEs	1	3	0	6	0

Population analysed: Patient 29 was randomized to receive 0.5 Units of CPP but inadvertently received 1 Unit. This patient's data was analyzed with the 1 Unit CPP group.

Primary outcome: Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity

Time frame: day of thru 6 days after transfusion. Count of participants. Unit: Participants

Measure	Cohort 1 With 0.5 Units of CPP n = 5	Cohort 2 With 1 Unit of CPP n = 7	Cohort 3 With 2 Units of CPP n = 6	Cohort 4 With 3 Units of CPP n = 6	1 Unit of LSP n = 4
Total Patients with Any AE	4	6	3	5	1
Total Patients with any AE	4	6	3	5	1
Total Patients with Mild AEs	4	4	1	5	1
Total Patients with Moderate AEs	1	1	3	1	0
Total Patients with Severe AEss	0	1	0	1	0
Total Patients with Life-threatening or Fatal AEs	1	1	2	2	0
Related to Investigational Product	1	2	2	2	0

Population analysed: Patient 29 was randomized to receive 0.5 Units of CPP but inadvertently received 1 Unit. This patient's data was analyzed with the 1 Unit CPP group.

Primary outcome: Number of Subject With Thrombotic Events

Time frame: 6 days after transfusion. Count of participants. Unit: Participants

Measure	Cohort 1 With 0.5 Units of CPP n = 5	Cohort 2 With 1 Unit of CPP n = 7	Cohort 3 With 2 Units of CPP n = 6	Cohort 4 With 3 Units of CPP n = 6	1 Unit of LSP n = 4
Value	0	0	0	0	0

Adverse events

Time frame: Day of transfusion thru 6 days after transfusion. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1 With 0.5 Units of CPP	1 of 5 (20%)	4 of 5 (80%)	1 of 5
Cohort 2 With 1 Unit of CPP	2 of 7 (28.6%)	6 of 7 (85.7%)	1 of 7
Cohort 3 With 2 Units of CPP	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Cohort 4 With 3 Units of CPP	2 of 6 (33.3%)	5 of 6 (83.3%)	1 of 6
1 Unit of LSP	0 of 4 (0%)	1 of 4 (25%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30204953Slichter SJ, Dumont LJ, Cancelas JA, Jones M, Gernsheimer TB, Szczepiorkowski ZM, Dunbar NM, Prakash G, Medlin S, Rugg N, Kinne B, Macdonald VW, Housler G, Valiyaveettil M, Hmel P, Ransom JH. Safety and efficacy of cryopreserved platelets in bleeding patients with thrombocytopenia. Transfusion. 2018 Sep;58(9):2129-2138. doi: 10.1111/trf.14780.

Related trials for Thrombocytopenia

RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sherrill J Slichter, MD principal investigator

Bloodworks

Terry B Gernsheimer, MD principal investigator

University of Washington, Division of Hematology

Zbigniew Szczepiorkowski, MD, PhD principal investigator

Center for Transfusion Medicine Research, Lebanon, NH

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CPP and LSP in people with Thrombocytopenia, run by U.S. Army Medical Research and Development Command at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (AEs) by Level of Severity (time frame: day of thru 6 days after transfusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02078284, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2021.