HealthyPhase 2NCT02653443
A Randomized, Multi-center, Open-label, Paired Controlled, Crossover In Vivo Study
A Phase 2 study testing Autologous apheresis Platelet Components, prepared with the INTERCEPT Blood System for Platelets. and Autologous apheresis Conventional untreated Platelet Components in people with Healthy, run by Cerus Corporation at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Autologous apheresis Platelet Components, prepared with the INTERCEPT Blood System for Platelets. and Autologous apheresis Conventional untreated Platelet Components
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2015to May 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- Splenectomized subjects
- History of known hypersensitivity to indium or chromium
- Participation in another clinical study currently or within the past 28 days
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hoxworth Blood Center
Cincinnati, Ohio, 45267
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766
About this study
Official title: A Randomized, Multi-center, Open-label, Paired Controlled, Crossover In Vivo Study to Assess the Recovery and Lifespan of Radiolabeled Autologous INTERCEPT Treated Apheresis Platelet Components Suspended in Nominal 35% Plasma and 65% InterSol Stored for 6 or 7 Days
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.
Read the detailed description
For each of the 2 study donation periods, this study will have the following procedures: single or double dose platelet apheresis collection, pathogen inactivation with INTERCEPT Blood System treatment, storage for 6 or 7 days (depending on the period and randomization scheme) at 20°C to 24°C with agitation, collection of "fresh" autologous platelets, radiolabeling, infusion of fresh and stored INTERCEPT Blood System-treated radiolabeled autologous platelets, and collection of blood samples for assessment of platelet recovery and survival (lifespan). There will be a minimum wash-out period of two weeks between the two study periods.
Apheresis platelets will be collected using the Amicus separator and stored for 6 or 7 days (depending on the period and randomization scheme) in 35% plasma/65% InterSol.
Procedures will be as follows: On Day 0, each healthy volunteer subject has apheresis platelets collected. INTERCEPT Blood System treatment will begin on either the day of donation (Day 0) or the day following donation (Day 1) and will be completed within 24 hours after collection. Platelets will then be stored for 6 or 7 days after collection (depending on the period and randomization scheme) at 22°C ±2°C with agitation. Aliquots for in vitro platelet function will be taken on Day 0/1 before INTERCEPT Blood System treatment and on Day 6 or 7. On Day 6 or 7, healthy volunteers will return to the site, and 43 mL of blood will be drawn into a syringe containing 9 mL of Anticoagulant Citrate Dextrose Solution, Formula A (ACD-A). Fresh platelets will be prepared from this sample. An aliquot (10-20 mL) of the stored INTERCEPT Blood System for platelets will be aseptically removed from each subject's test container.
Previously stored (Test) and fresh (Control) platelets will be radiolabeled according to randomization assignment with either Chromium-51 (51Cr) (≤20 μCi) as sodium radiochromate (Na251CrO4) or Indium-111 (111In) (≤15 μCi) as indium oxine, following the labeling and washing procedures outlined by the Biomedical Excellence for Safer Transfusion (BEST) Collaborative. The isotope labels will be assigned randomly with equal probability that fresh platelets and stored INTERCEPT Blood System for platelets will be labeled with each isotope., and the same randomization assignment of isotope labels will be utilized for both donation periods for the same subject. Aliquots of the fresh and stored platelets will be radiolabeled in tubes with the standard techniques. After radiolabeling, the autologous fresh and stored INTERCEPT Blood System for platelets will be simultaneously infused into the subject (approximately 10-30 mL). Negative pregnancy test for females of childbearing potential are required before infusion.
Blood samples for radioactivity measurements will be drawn immediately before infusion and at approximately 0, 0.5, 1, and 2 hours post-infusion, and then 6 more samples will be drawn at 1, 2, 3, 4 (or 6), 7, and 11±1 days post-infusion, at approximately the same time of day as the radiolabeled platelet infusion was administered (±4 hours).
Patients will be monitored for safety (adverse events) from the beginning of the study until 10 days following the infusion of radiolabelled platelets in period 2.
Radioactivity measurements Samples will be obtained from the radiolabeled fresh and stored INTERCEPT Blood System for platelets before infusion and used as a radioactive standard. By measuring the volume infused, the total dose of radioactivity infused will be calculated. In vitro elution of the label from the transfused platelets will be determined by the BEST elution assessment method, as well as the in vivo elution of radioactivity from the serial blood samples obtained post-infusion of the labeled platelets.
The standard as well as the subject's whole-blood samples will be corrected for elution and also for the residual activity in the cellular fraction one day after the infusion. Data points 24 hours post-infusion will be used to calculate in vivo recovery after all radioactive corrections have been made. The radioactivity of the samples will be determined by use of a gamma counter. A multiple-hit model will be used to estimate the survival of the radioactively labeled platelets.
- Conditions
- Healthy
- Being tested
- Autologous apheresis Platelet Components, prepared with the INTERCEPT Blood System for Platelets., Autologous apheresis Conventional untreated Platelet Components
- Keywords
- INTERCEPT, Platelet, Pathogen Inactivation, Platelets Components Stored, Therapeutic Efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous apheresis Platelet Components, prepared with the INTERCEPT Blood System for Platelets.Biological
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.
Autologous apheresis Conventional untreated Platelet ComponentsBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Day 6 | Experimental | 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). Receives: Biological: Autologous apheresis Platelet Components, prepared with the INTERCEPT Blood System for Platelets.; Biological: Autologous apheresis Conventional untreated Platelet Components |
| Day 7 | Experimental | 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). Receives: Biological: Autologous apheresis Platelet Components, prepared with the INTERCEPT Blood System for Platelets.; Biological: Autologous apheresis Conventional untreated Platelet Components |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post infusion recovery of the Test platelets compared to fresh platelets.
Measured: 16 Days
Post infusion recovery of the Test platelets compared to fresh platelets.
Measured: 17 Days
Post infusion lifespan of Test platelets compared to fresh platelets.
Measured: 16 Days
Post infusion lifespan of Test platelets compared to fresh platelets.
Measured: 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.
Measured: 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.
Measured: 17 Days
Body Mass Index (kg/m^2)
Measured: 16 Days
Body Mass Index (kg/m^2)
Measured: 17 Days
Hematocrit (g/dL)
Measured: 16 Days
Hematocrit (g/dL)
Measured: 17 Days
Hemoglobin (g/dL)
Measured: 16 Days
Hemoglobin (g/dL)
Measured: 17 Days
Red Blood Cell Count (x10^12/L)
Measured: 16 Days
Red Blood Cell Count (x10^12/L)
Measured: 17 Days
Platelet Count (×10^3μL)
Measured: 16 Days
Platelet Count (×10^3μL)
Measured: 17 Days
White Blood Cell Count - with Differential (x10^9/L)
Measured: 16 Days
White Blood Cell Count - with Differential (x10^9/L)
Measured: 17 Days
Blood Urea Nitrogen (mg/dL)
Measured: 16 Days
Blood Urea Nitrogen (mg/dL)
Measured: 17 Days
Calcium (mg/dL)
Measured: 16 Days
Calcium (mg/dL)
Measured: 17 Days
Chloride (mEq/L)
Measured: 16 Days
Chloride (mEq/L)
Measured: 17 Days
Creatinine (mg/dL)
Measured: 16 Days
Creatinine (mg/dL)
Measured: 17 Days
Glucose (mg/dL)
Measured: 16 Days
Glucose (mg/dL)
Measured: 17 Days
Potassium (mEq/L)
Measured: 16 Days
Potassium (mEq/L)
Measured: 17 Days
Sodium (mEq/L)
Measured: 16 Days
Sodium (mEq/L)
Measured: 17 Days
Post infusion recovery of the platelets at Day 6 platelets compared to Day 7 platelets.
Measured: 16 Days
Post infusion recovery of the platelets at Day 6 platelets compared to Day 7 platelets.
Measured: 17 Days
Post infusion lifespan of the platelets at Day 6 platelets compared to Day 7 platelets.
Measured: 16 Days
Post infusion lifespan of the platelets at Day 6 platelets compared to Day 7 platelets.
Measured: 17 Days
Secondary outcomes (32)
pH (pH)
Measured: 16 Days
pH (pH)
Measured: 17 Days
Platelet count (×10^3/μL)
Measured: 16 Days
Platelet count (×10^3/μL)
Measured: 17 Days
Platelet dose (×10^11 cells/component)
Measured: 16 Days
Platelet dose (×10^11 cells/component)
Measured: 17 Days
Mean platelet volume (MPV) (fL)
Measured: 16 Days
Mean platelet volume (MPV) (fL)
Measured: 17 Days
Morphology score (Kunicki Score)
Measured: 16 Days
Morphology score (Kunicki Score)
Measured: 17 Days
Component volume (mL)
Measured: 16 Days
Component volume (mL)
Measured: 17 Days
Glucose (mmol/L)
Measured: 16 Days
Glucose (mmol/L)
Measured: 17 Days
Lactate (mmol/L)
Measured: 16 Days
Lactate (mmol/L)
Measured: 17 Days
pO2 (mm Hg)
Measured: 16 Days
pO2 (mm Hg)
Measured: 17 Days
pCO2 (mm Hg)
Measured: 16 Days
pCO2 (mm Hg)
Measured: 17 Days
Bicarbonate (HCO3-) (mmol/L)
Measured: 16 Days
Bicarbonate (HCO3-) (mmol/L)
Measured: 17 Days
Lactate dehydrogenase (IU/L)
Measured: 16 Days
Lactate dehydrogenase (IU/L)
Measured: 17 Days
Hypotonic Shock Response (HSR) (%)
Measured: 16 Days
Hypotonic Shock Response (HSR) (%)
Measured: 17 Days
Extent of Shape Change (ESC) (%)
Measured: 16 Days
Extent of Shape Change (ESC) (%)
Measured: 17 Days
p-selectin expression (CD62) (% activation)
Measured: 16 Days
p-selectin expression (CD62) (% activation)
Measured: 17 Days
Adenosine 5'-Triphosphate (ATP) (nmol/10^8 platelets)
Measured: 16 Days
Adenosine 5'-Triphosphate (ATP) (nmol/10^8 platelets)
Measured: 17 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cerus Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02653443
- Sponsor's protocol ID
- CLI 00116
- Status last verified
- Jan 2018
- First submitted
- 2 Dec 2015
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multi-center, Open-label, Paired Controlled, Crossover In Vivo Study to Assess the Recovery and Lifespan of Radiolabeled Autologous INTERCEPT Treated Apheresis Platelet Components Suspended in Nominal 35% Plasma and 65% InterSol Stored for 6 or 7 Days
- ClinicalTrials.gov ID
- NCT02653443
- Acronym / sponsor ID
- CLI 00116
- Conditions
- Healthy
- Keywords
- INTERCEPT, Platelet, Pathogen Inactivation, Platelets Components Stored, Therapeutic Efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Cerus CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 12 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
For each of the 2 study donation periods, this study will have the following procedures: single or double dose platelet apheresis collection, pathogen inactivation with INTERCEPT Blood System treatment, storage for 6 or 7 days (depending on the period and randomization scheme) at 20°C to 24°C with agitation, collection of "fresh" autologous platelets, radiolabeling, infusion of fresh and stored INTERCEPT Blood System-treated radiolabeled autologous platelets, and collection of blood samples for assessment of platelet recovery and survival (lifespan). There will be a minimum wash-out period of two weeks between the two study periods.
Apheresis platelets will be collected using the Amicus separator and stored for 6 or 7 days (depending on the period and randomization scheme) in 35% plasma/65% InterSol.
Procedures will be as follows: On Day 0, each healthy volunteer subject has apheresis platelets collected. INTERCEPT Blood System treatment will begin on either the day of donation (Day 0) or the day following donation (Day 1) and will be completed within 24 hours after collection. Platelets will then be stored for 6 or 7 days after collection (depending on the period and randomization scheme) at 22°C ±2°C with agitation. Aliquots for in vitro platelet function will be taken on Day 0/1 before INTERCEPT Blood System treatment and on Day 6 or 7. On Day 6 or 7, healthy volunteers will return to the site, and 43 mL of blood will be drawn into a syringe containing 9 mL of Anticoagulant Citrate Dextrose Solution, Formula A (ACD-A). Fresh platelets will be prepared from this sample. An aliquot (10-20 mL) of the stored INTERCEPT Blood System for platelets will be aseptically removed from each subject's test container.
Previously stored (Test) and fresh (Control) platelets will be radiolabeled according to randomization assignment with either Chromium-51 (51Cr) (≤20 μCi) as sodium radiochromate (Na251CrO4) or Indium-111 (111In) (≤15 μCi) as indium oxine, following the labeling and washing procedures outlined by the Biomedical Excellence for Safer Transfusion (BEST) Collaborative. The isotope labels will be assigned randomly with equal probability that fresh platelets and stored INTERCEPT Blood System for platelets will be labeled with each isotope., and the same randomization assignment of isotope labels will be utilized for both donation periods for the same subject. Aliquots of the fresh and stored platelets will be radiolabeled in tubes with the standard techniques. After radiolabeling, the autologous fresh and stored INTERCEPT Blood System for platelets will be simultaneously infused into the subject (approximately 10-30 mL). Negative pregnancy test for females of childbearing potential are required before infusion.
Blood samples for radioactivity measurements will be drawn immediately before infusion and at approximately 0, 0.5, 1, and 2 hours post-infusion, and then 6 more samples will be drawn at 1, 2, 3, 4 (or 6), 7, and 11±1 days post-infusion, at approximately the same time of day as the radiolabeled platelet infusion was administered (±4 hours).
Patients will be monitored for safety (adverse events) from the beginning of the study until 10 days following the infusion of radiolabelled platelets in period 2.
Radioactivity measurements Samples will be obtained from the radiolabeled fresh and stored INTERCEPT Blood System for platelets before infusion and used as a radioactive standard. By measuring the volume infused, the total dose of radioactivity infused will be calculated. In vitro elution of the label from the transfused platelets will be determined by the BEST elution assessment method, as well as the in vivo elution of radioactivity from the serial blood samples obtained post-infusion of the labeled platelets.
The standard as well as the subject's whole-blood samples will be corrected for elution and also for the residual activity in the cellular fraction one day after the infusion. Data points 24 hours post-infusion will be used to calculate in vivo recovery after all radioactive corrections have been made. The radioactivity of the samples will be determined by use of a gamma counter. A multiple-hit model will be used to estimate the survival of the radioactively labeled platelets.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Day 6 | Experimental | Biological: Autologous apheresis Platelet Components, prepared with the INTERCEPT Blood System for Platelets., Biological: Autologous apheresis Conventional untreated Platelet ComponentsEach 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 | Experimental | Biological: Autologous apheresis Platelet Components, prepared with the INTERCEPT Blood System for Platelets., Biological: Autologous apheresis Conventional untreated Platelet ComponentsEach 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (9 listed)
- 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)
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 |
|---|---|---|
| Autologous apheresis Platelet Components, prepared with the INTERCEPT Blood System for Platelets.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. | Biological | Day 6, Day 7 |
| Autologous apheresis Conventional untreated Platelet ComponentsEach 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. | Biological | Day 6, Day 7 |
Primary outcome
Post infusion recovery of the Test platelets compared to fresh platelets.
Time frame: 16 Days
Post infusion recovery of the Test platelets compared to fresh platelets.
Time frame: 17 Days
Post infusion lifespan of Test platelets compared to fresh platelets.
Time frame: 16 Days
Post infusion lifespan of Test platelets compared to fresh platelets.
Time frame: 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.
Time frame: 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.
Time frame: 17 Days
Body Mass Index (kg/m^2)
Time frame: 16 Days
Body Mass Index (kg/m^2)
Time frame: 17 Days
Hematocrit (g/dL)
Time frame: 16 Days
Hematocrit (g/dL)
Time frame: 17 Days
Hemoglobin (g/dL)
Time frame: 16 Days
Hemoglobin (g/dL)
Time frame: 17 Days
Red Blood Cell Count (x10^12/L)
Time frame: 16 Days
Red Blood Cell Count (x10^12/L)
Time frame: 17 Days
Platelet Count (×10^3μL)
Time frame: 16 Days
Platelet Count (×10^3μL)
Time frame: 17 Days
White Blood Cell Count - with Differential (x10^9/L)
Time frame: 16 Days
White Blood Cell Count - with Differential (x10^9/L)
Time frame: 17 Days
Blood Urea Nitrogen (mg/dL)
Time frame: 16 Days
Blood Urea Nitrogen (mg/dL)
Time frame: 17 Days
Calcium (mg/dL)
Time frame: 16 Days
Calcium (mg/dL)
Time frame: 17 Days
Chloride (mEq/L)
Time frame: 16 Days
Chloride (mEq/L)
Time frame: 17 Days
Creatinine (mg/dL)
Time frame: 16 Days
Creatinine (mg/dL)
Time frame: 17 Days
Glucose (mg/dL)
Time frame: 16 Days
Glucose (mg/dL)
Time frame: 17 Days
Potassium (mEq/L)
Time frame: 16 Days
Potassium (mEq/L)
Time frame: 17 Days
Sodium (mEq/L)
Time frame: 16 Days
Sodium (mEq/L)
Time frame: 17 Days
Post infusion recovery of the platelets at Day 6 platelets compared to Day 7 platelets.
Time frame: 16 Days
Post infusion recovery of the platelets at Day 6 platelets compared to Day 7 platelets.
Time frame: 17 Days
Post infusion lifespan of the platelets at Day 6 platelets compared to Day 7 platelets.
Time frame: 16 Days
Post infusion lifespan of the platelets at Day 6 platelets compared to Day 7 platelets.
Time frame: 17 Days
32 secondary outcomes
pH (pH)
Time frame: 16 Days
pH (pH)
Time frame: 17 Days
Platelet count (×10^3/μL)
Time frame: 16 Days
Platelet count (×10^3/μL)
Time frame: 17 Days
Platelet dose (×10^11 cells/component)
Time frame: 16 Days
Platelet dose (×10^11 cells/component)
Time frame: 17 Days
Mean platelet volume (MPV) (fL)
Time frame: 16 Days
Mean platelet volume (MPV) (fL)
Time frame: 17 Days
Morphology score (Kunicki Score)
Time frame: 16 Days
Morphology score (Kunicki Score)
Time frame: 17 Days
Component volume (mL)
Time frame: 16 Days
Component volume (mL)
Time frame: 17 Days
Glucose (mmol/L)
Time frame: 16 Days
Glucose (mmol/L)
Time frame: 17 Days
Lactate (mmol/L)
Time frame: 16 Days
Lactate (mmol/L)
Time frame: 17 Days
pO2 (mm Hg)
Time frame: 16 Days
pO2 (mm Hg)
Time frame: 17 Days
pCO2 (mm Hg)
Time frame: 16 Days
pCO2 (mm Hg)
Time frame: 17 Days
Bicarbonate (HCO3-) (mmol/L)
Time frame: 16 Days
Bicarbonate (HCO3-) (mmol/L)
Time frame: 17 Days
Lactate dehydrogenase (IU/L)
Time frame: 16 Days
Lactate dehydrogenase (IU/L)
Time frame: 17 Days
Hypotonic Shock Response (HSR) (%)
Time frame: 16 Days
Hypotonic Shock Response (HSR) (%)
Time frame: 17 Days
Extent of Shape Change (ESC) (%)
Time frame: 16 Days
Extent of Shape Change (ESC) (%)
Time frame: 17 Days
p-selectin expression (CD62) (% activation)
Time frame: 16 Days
p-selectin expression (CD62) (% activation)
Time frame: 17 Days
Adenosine 5'-Triphosphate (ATP) (nmol/10^8 platelets)
Time frame: 16 Days
Adenosine 5'-Triphosphate (ATP) (nmol/10^8 platelets)
Time frame: 17 Days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Autologous apheresis Platelet Components, prepared with the INTERCEPT Blood System for Platelets. and Autologous apheresis Conventional untreated Platelet Components in people with Healthy, run by Cerus Corporation at 2 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 7 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: stopped early, as of the sponsor's last update on 26 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Post infusion recovery of the Test platelets compared to fresh platelets. (time frame: 16 Days). The study lists 36 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jan 2018.