Trial · NCT02078284

Phase 1 Safety Study of Dimethyl Sulfoxide Cryopreserved Platelets

NCT02078284, Phase 1, Completed, U.S. Army Medical Research and Development Command; results first posted 2021-05-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Phase 1 Safety Study of Dimethyl Sulfoxide Cryopreserved Platelets. Trials, record NCT02078284. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02078284

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Phase 1 Safety Study of Dimethyl Sulfoxide Cryopreserved Platelets
NCT number: NCT02078284
Status: Completed
Phases: Phase 1
Enrollment: 28 participants, actual
Lead sponsor: U.S. Army Medical Research and Development Command
Conditions: Thrombocytopenia
Interventions: CPP, LSP
First posted: 2014-03-05
Last updated: 2021-05-20
Results first posted: 2021-05-20

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Adverse Events (AEs) by Level of Severity	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.
Primary	Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity	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.
Primary	Number of Subject With Thrombotic Events	6 days after transfusion	Subjects with any signs or symptoms of thrombotic events.
Other	Corrected Count Increments (CCI)	Day 1 up to 6 hrs after transfusion and Day 2 approx 24 hrs after transfusion	Corrected Count Increments Expressed in units of mm\^2/(µL\*10¹¹ platelets) (CCI) in the 6 hour period after the study platelet transfusion and on Day 2 (approximately 24 hours after the study platelet transfusion)
Other	Count Increment	On Day 1 up to 6 hours after transfusion and on Day 2 approximately 24 hours after transfusion	Count Increment expressed in units of platelets (x10\^3 µL) (CI)

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Adverse Events (AEs) by Level of Severity	day of thru 6 days after transfusion	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.	adverse events	NUMBER
PRIMARY	Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity	day of thru 6 days after transfusion	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.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Subject With Thrombotic Events	6 days after transfusion		Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Corrected Count Increments (CCI)	Day 1 up to 6 hrs after transfusion and Day 2 approx 24 hrs after transfusion		mm^2/(μL*1011 platelets)	MEAN
OTHER_PRE_SPECIFIED	Count Increment	On Day 1 up to 6 hours after transfusion and on Day 2 approximately 24 hours after transfusion		platelets*10^3 µL	MEAN

Source ClinicalTrials.gov

Results by group85

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Adverse Events (AEs) by Level of Severity	Cohort 1 With 0.5 Units of CPP	Total number of AEs	8	adverse events
Adverse Events (AEs) by Level of Severity	Cohort 2 With 1 Unit of CPP	Total number of AEs	18	adverse events
Adverse Events (AEs) by Level of Severity	Cohort 3 With 2 Units of CPP	Total number of AEs	6	adverse events
Adverse Events (AEs) by Level of Severity	Cohort 4 With 3 Units of CPP	Total number of AEs	21	adverse events
Adverse Events (AEs) by Level of Severity	1 Unit of LSP	Total number of AEs	5	adverse events
Adverse Events (AEs) by Level of Severity	Cohort 1 With 0.5 Units of CPP	Total mild AEs	6	adverse events
Adverse Events (AEs) by Level of Severity	Cohort 2 With 1 Unit of CPP	Total mild AEs	11	adverse events
Adverse Events (AEs) by Level of Severity	Cohort 3 With 2 Units of CPP	Total mild AEs	1	adverse events
Adverse Events (AEs) by Level of Severity	Cohort 4 With 3 Units of CPP	Total mild AEs	9	adverse events
Adverse Events (AEs) by Level of Severity	1 Unit of LSP	Total mild AEs	5	adverse events

1 to 10 of 85Source ClinicalTrials.gov

See all 85 results by group

Participant flow15

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Cohort 1 With 0.5 Units of CPP	5
Overall Study	STARTED	Cohort 2 With 1 Unit of CPP	7
Overall Study	STARTED	Cohort 3 With 2 Units of CPP	6
Overall Study	STARTED	Cohort 4 With 3 Units of CPP	6
Overall Study	STARTED	1 Unit of LSP	4
Overall Study	COMPLETED	Cohort 1 With 0.5 Units of CPP	5
Overall Study	COMPLETED	Cohort 2 With 1 Unit of CPP	7
Overall Study	COMPLETED	Cohort 3 With 2 Units of CPP	6
Overall Study	COMPLETED	Cohort 4 With 3 Units of CPP	6
Overall Study	COMPLETED	1 Unit of LSP	4

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events260

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	Cohort 1 With 0.5 Units of CPP	0	5	0
other	Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	Cohort 2 With 1 Unit of CPP	1	7	1
other	Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	Cohort 3 With 2 Units of CPP	0	6	0
other	Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	Cohort 4 With 3 Units of CPP	0	6	0
other	Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	1 Unit of LSP	0	4	0
other	Affect lability	Psychiatric disorders	Cohort 1 With 0.5 Units of CPP	0	5	0
other	Affect lability	Psychiatric disorders	Cohort 2 With 1 Unit of CPP	0	7	0
other	Affect lability	Psychiatric disorders	Cohort 3 With 2 Units of CPP	0	6	0
other	Affect lability	Psychiatric disorders	Cohort 4 With 3 Units of CPP	1	6	1
other	Affect lability	Psychiatric disorders	1 Unit of LSP	0	4	0

1 to 10 of 260Source ClinicalTrials.gov

See all 260 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Cohort 1 With 0.5 Units of CPP	1	5
Total, all-cause mortality	Cohort 2 With 1 Unit of CPP	1	7
Total, all-cause mortality	Cohort 3 With 2 Units of CPP	0	6
Total, all-cause mortality	Cohort 4 With 3 Units of CPP	1	6
Total, all-cause mortality	1 Unit of LSP	0	4
Total, other adverse events	Cohort 1 With 0.5 Units of CPP	4	5
Total, other adverse events	Cohort 2 With 1 Unit of CPP	6	7
Total, other adverse events	Cohort 3 With 2 Units of CPP	3	6
Total, other adverse events	Cohort 4 With 3 Units of CPP	5	6
Total, other adverse events	1 Unit of LSP	1	4

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
30204953	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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