A Randomized, Multi-center, Open-label, Paired Controlled, Crossover In Vivo Study
1 other identifier
interventional
14
1 country
2
Brief Summary
The objective of this study is to test the hypothesis that INTERCEPT Blood System for platelet components stored for 6 or 7 days after INTERCEPT Blood System treatment retain sufficient viability for therapeutic efficacy. The post-infusion recovery and lifespan of autologous INTERCEPT Blood System for platelet components in 35% plasma/65% InterSol (Test platelets) stored for 6 or 7 days will be measured in comparison to "fresh" autologous radiolabeled platelets (Control platelets) according to FDA guidance for platelet testing (FDA 1999). Recovery and lifespan results between components stored for 6 and 7 days will also be assessed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 healthy
Started Dec 2015
Shorter than P25 for phase_2 healthy
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 2, 2015
CompletedFirst Posted
Study publicly available on registry
January 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedJanuary 26, 2018
January 1, 2018
5 months
December 2, 2015
January 24, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (36)
Post infusion recovery of the Test platelets compared to fresh platelets.
16 Days
Post infusion recovery of the Test platelets compared to fresh platelets.
17 Days
Post infusion lifespan of Test platelets compared to fresh platelets.
16 Days
Post infusion lifespan of Test platelets compared to fresh platelets.
17 Days
Adverse events: any untold medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment.
16 Days
Adverse events: any untold medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment.
17 Days
Body Mass Index (kg/m^2)
16 Days
Body Mass Index (kg/m^2)
17 Days
Hematocrit (g/dL)
16 Days
Hematocrit (g/dL)
17 Days
Hemoglobin (g/dL)
16 Days
Hemoglobin (g/dL)
17 Days
Red Blood Cell Count (x10^12/L)
16 Days
Red Blood Cell Count (x10^12/L)
17 Days
Platelet Count (×10^3μL)
16 Days
Platelet Count (×10^3μL)
17 Days
White Blood Cell Count - with Differential (x10^9/L)
16 Days
White Blood Cell Count - with Differential (x10^9/L)
17 Days
Blood Urea Nitrogen (mg/dL)
16 Days
Blood Urea Nitrogen (mg/dL)
17 Days
Calcium (mg/dL)
16 Days
Calcium (mg/dL)
17 Days
Chloride (mEq/L)
16 Days
Chloride (mEq/L)
17 Days
Creatinine (mg/dL)
16 Days
Creatinine (mg/dL)
17 Days
Glucose (mg/dL)
16 Days
Glucose (mg/dL)
17 Days
Potassium (mEq/L)
16 Days
Potassium (mEq/L)
17 Days
Sodium (mEq/L)
16 Days
Sodium (mEq/L)
17 Days
Post infusion recovery of the platelets at Day 6 platelets compared to Day 7 platelets.
16 Days
Post infusion recovery of the platelets at Day 6 platelets compared to Day 7 platelets.
17 Days
Post infusion lifespan of the platelets at Day 6 platelets compared to Day 7 platelets.
16 Days
Post infusion lifespan of the platelets at Day 6 platelets compared to Day 7 platelets.
17 Days
Secondary Outcomes (32)
pH (pH)
16 Days
pH (pH)
17 Days
Platelet count (×10^3/μL)
16 Days
Platelet count (×10^3/μL)
17 Days
Platelet dose (×10^11 cells/component)
16 Days
- +27 more secondary outcomes
Study Arms (2)
Day 6
EXPERIMENTALEach subject will provide two apheresis platelet donations (one per period) and receive two infusions (one per period) of autologous radiolabeled fresh platelets combined with INTERCEPT treated platelet components stored for either 6 or 7 days (approximately 10 to 30 mL).
Day 7
EXPERIMENTALEach subject will provide two apheresis platelet donations (one per period) and receive two infusions (one per period) of autologous radiolabeled fresh platelets combined with conventional untreated platelet components stored for either 6 or 7 days (approximately 10 to 30 mL).
Interventions
Each subject will provide two apheresis platelet donations (one per period) and receive two infusions (one per period) of autologous radiolabeled fresh platelets combined with INTERCEPT treated platelet components stored for either 6 or 7 days (approximately 10 to 30 mL). Platelets are administered by intravenous infusion in a peripheral vein via 19-gauge butterfly infusion needle.
Each subject will provide two apheresis platelet donations (one per period) and receive two infusions (one per period) of autologous radiolabeled fresh platelets combined with conventional untreated platelet components stored for either 6 or 7 days (approximately 10 to 30 mL). Platelets are administered by intravenous infusion in a peripheral vein via 19-gauge butterfly infusion needle.
Eligibility Criteria
You may qualify if:
- Normal health status (as determined by the Investigator review of medical history and blood donor physical exam)
- Meet FDA, American Association of Blood Banks (AABB), and site guidelines for blood donation or apheresis platelet donation
- Complete blood count (CBC) and serum chemistry values within established reference ranges or within guidelines as above.
- Pre-donation platelet count of more than 150×10\^9 platelets/L
- Negative blood donor screening test panel for Human Immunodeficiency virus (HIV), Hepatitis B virus (HBV), Hepatitis C virus (HCV), Human T-Lymphotropic virus (HTLV), syphilis, and West Nile virus (WNV)
- Male and female subjects of childbearing potential must agree to use a medically acceptable method of contraception throughout the study. A barrier method of contraception must be included, regardless of other methods.
- Signed and dated informed consent form
You may not qualify if:
- Clinically significant acute or chronic disease (as determined by the Investigator)
- Pregnant or nursing females
- Male or female subjects of childbearing potential not using effective contraception
- Disease states or conditions that preclude blood donation or apheresis platelet donation per AABB reference standards
- Treatment with aspirin or aspirin-containing medications within 7 days of apheresis or treatment with non-steroidal anti inflammatory drugs (NSAID), anti-platelet agents or other drugs affecting platelet viability within 3 days of apheresis (e.g. ibuprofen or other NSAIDs)
- Subject received platelet inhibitor within 14 days of donation (e.g. clopidogrel, ticlopidine)
- Splenectomized subjects
- History of known hypersensitivity to indium or chromium
- Participation in another clinical study currently or within the past 28 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766, United States
Hoxworth Blood Center
Cincinnati, Ohio, 45267, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2015
First Posted
January 12, 2016
Study Start
December 1, 2015
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
January 26, 2018
Record last verified: 2018-01