Ignite Creation Date:
2024-05-06 @ 1:26 PM
Last Modification Date:
2024-10-26 @ 1:14 PM
Study NCT ID:
NCT04022889
Status:
COMPLETED
Last Update Posted:
2022-10-27
First Post:
2019-07-09
Brief Title:
In Vivo Study to Assess the Recovery and Survival of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100 Plasma Stored for up to 7 Days
Sponsor:
Cerus Corporation
Organization:
Cerus Corporation
Study Overview
Official Title:
A Randomized Multi-center Open-label Controlled In Vivo Study to Assess the Recovery and Survival of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100 Plasma Stored for up to 7 Days
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The principle objective of this study is to evaluate the hypothesis that INTERCEPT Platelets in 100 plasma stored for 5 or more days up to 7 days after apheresis collection retain sufficient viability for therapeutic transfusion efficacy The post-infusion recovery and survival of autologous radiolabeled 7 day INTERCEPT platelets Test stored in 100 plasma will be measured in comparison to fresh autologous radiolabeled platelets Control according to FDA guidance for platelet testing FDA 1999 in Stage 2 of this study protocol
A secondary objective is to compare the recovery and survival results for Test platelets prepared for radiolabeling using the procedures outlined by the Biomedical Excellence for Safer Transfusion Collaboration BEST or a variation of the BEST procedure referred to as Variant 1 in Stage 1 of this study protocol Cerus has demonstrated that the Variant 1 method which does not incorporate an initial soft spin in the presence of ACD A results in improved in vitro platelet recovery and quality during preparation for radiolabeling compared to the BEST procedure This comparison will evaluate the hypothesis that preparation methods prior to radiolabeling may influence in vitro quality of the radiolabeled platelets and post-infusion viability outcomes
A secondary objective is to compare the recovery and survival results for Test platelets prepared for radiolabeling using the procedures outlined by the Biomedical Excellence for Safer Transfusion Collaboration BEST or a variation of the BEST procedure referred to as Variant 1 in Stage 1 of this study protocol Cerus has demonstrated that the Variant 1 method which does not incorporate an initial soft spin in the presence of ACD A results in improved in vitro platelet recovery and quality during preparation for radiolabeling compared to the BEST procedure This comparison will evaluate the hypothesis that preparation methods prior to radiolabeling may influence in vitro quality of the radiolabeled platelets and post-infusion viability outcomes
Detailed Description:
The study will be performed in two stages Stage 1 is a randomized 2-period crossover design Test platelets stored for 7 days will be radiolabeled based on either the BEST or Variant 1 methods depending on the period and randomization scheme for the Test platelets for 12 healthy subjects The recovery and survival for Test platelets prepared with the BEST and Variant 1 methods will be compared with each other and against the fresh platelet Control With agreement from the FDA BQ200481 July 8 2020 completion of Stage 1 is not required
Stage 2 is a single arm design Test platelets from 24 healthy subjects stored for 7 days will be prepared for radiolabeling following the Variant 1 methodology The recovery and survival for Test platelets will be compared against the fresh platelet Control Stage 1 subjects with evaluable Variant 1 method data will contribute to the requirement of the 24 subjects for Stage 2
For both stages the study population will consist of healthy subjects who meet the FDA AABB and site-specific research donor eligibility criteria for apheresis platelet donation Apheresis platelets will be collected in 100 plasma on the Trima Accel Automated Blood Collection system
Each study apheresis collection will be processed using the INTERCEPT Blood System for Platelets Platelet components containing 30 to 79 x1011 platelets in 300 to 420 mL of plasma will be processed using the INTERCEPT Dual Storage DS set The INTERCEPT process will begin on either the day of collection Day 0 or the day following donation Day 1 illumination must occur within 24 hours after the end of collection Test platelets components will be stored for up to 7 days from day of collection in 100 plasma
During each stage samples for in vitro platelet testing will be collected prior to INTERCEPT treatment Day 01 post INTERCEPT treatment and at the end of storage Day 7 see In vitro evaluation of platelets below
At the end of storage an aliquot of Test platelets will be aseptically removed from each subjects INTERCEPT platelet storage container for preparation of samples for radiolabeling using either the BEST Stage 1 or Variant 1 Stages 1 and 2 methodology The in vitro quality of the Test platelet sample used for radiolabeling will be assessed prior to and following the pre-radiolabeling platelet sample preparations The indices to be measured in Stage 1 are volume pH22C CD62P platelet count red blood cell RBC count and white blood cell WBC count Assessments of these indices will enable the determination of platelet processing recovery for each sample preparation method and evaluation of RBC and WBC contamination in samples prior to radiolabeling In Stage 2 platelet processing recovery during sample preparation will be calculated from volume and platelet count and pH22C will be measured in the sample prior to radiolabeling
On the day corresponding to the end of storage for the Test component healthy subjects will return to the site and 43 mL of whole blood WB will be drawn into a syringe containing 9 mL of Anticoagulant Citrate Dextrose Solution Formula A ACD A The sample will be used to prepare Control platelets following the BEST methodology Test and Control platelets will be randomly radiolabeled with either 51Cr approximately10-30μCi as sodium radiochromate Na251CrO4 or 111In approximately 10-30 μCi as indium oxine depending upon the randomization assignment and period as applicable Subjects will be randomized with equal probability to the radiolabeling sequences 111In51Cr vs 51Cr111In for TestControl The isotope labels will be assigned randomly with equal probability that Control and Test platelets will be labeled with each isotope and the same randomization assignment of isotope labels will be utilized for both apheresis collections for the same subject in Stage 1 After radiolabeling the autologous Control and Test platelet samples will be simultaneously infused into the subject approximately 10 30 mL A negative pregnancy test for females of childbearing potential is required before infusion
Blood samples will be drawn immediately before infusion and for radioactivity measurements at 1 hour 15 min and 2 hours 15 min post-infusion Day 0 and 6 more samples will be drawn at 1 2 3 4 or 5 or 6 7 or 8 and 111 days post-infusion DPI at approximately the same time of day as the radiolabeled platelet infusion was administered 4 hours The exact time of each sample draw will be recorded
For subjects enrolled in Stage 1 there will be a minimum washout period of four weeks between the two study periods eg four weeks after the last blood sample at 111 DPI in Period 1 Subjects will be monitored for safety adverse events from the first apheresis procedure until 24 hours after the last DPI blood sample is drawn
Stage 2 is a single arm design Test platelets from 24 healthy subjects stored for 7 days will be prepared for radiolabeling following the Variant 1 methodology The recovery and survival for Test platelets will be compared against the fresh platelet Control Stage 1 subjects with evaluable Variant 1 method data will contribute to the requirement of the 24 subjects for Stage 2
For both stages the study population will consist of healthy subjects who meet the FDA AABB and site-specific research donor eligibility criteria for apheresis platelet donation Apheresis platelets will be collected in 100 plasma on the Trima Accel Automated Blood Collection system
Each study apheresis collection will be processed using the INTERCEPT Blood System for Platelets Platelet components containing 30 to 79 x1011 platelets in 300 to 420 mL of plasma will be processed using the INTERCEPT Dual Storage DS set The INTERCEPT process will begin on either the day of collection Day 0 or the day following donation Day 1 illumination must occur within 24 hours after the end of collection Test platelets components will be stored for up to 7 days from day of collection in 100 plasma
During each stage samples for in vitro platelet testing will be collected prior to INTERCEPT treatment Day 01 post INTERCEPT treatment and at the end of storage Day 7 see In vitro evaluation of platelets below
At the end of storage an aliquot of Test platelets will be aseptically removed from each subjects INTERCEPT platelet storage container for preparation of samples for radiolabeling using either the BEST Stage 1 or Variant 1 Stages 1 and 2 methodology The in vitro quality of the Test platelet sample used for radiolabeling will be assessed prior to and following the pre-radiolabeling platelet sample preparations The indices to be measured in Stage 1 are volume pH22C CD62P platelet count red blood cell RBC count and white blood cell WBC count Assessments of these indices will enable the determination of platelet processing recovery for each sample preparation method and evaluation of RBC and WBC contamination in samples prior to radiolabeling In Stage 2 platelet processing recovery during sample preparation will be calculated from volume and platelet count and pH22C will be measured in the sample prior to radiolabeling
On the day corresponding to the end of storage for the Test component healthy subjects will return to the site and 43 mL of whole blood WB will be drawn into a syringe containing 9 mL of Anticoagulant Citrate Dextrose Solution Formula A ACD A The sample will be used to prepare Control platelets following the BEST methodology Test and Control platelets will be randomly radiolabeled with either 51Cr approximately10-30μCi as sodium radiochromate Na251CrO4 or 111In approximately 10-30 μCi as indium oxine depending upon the randomization assignment and period as applicable Subjects will be randomized with equal probability to the radiolabeling sequences 111In51Cr vs 51Cr111In for TestControl The isotope labels will be assigned randomly with equal probability that Control and Test platelets will be labeled with each isotope and the same randomization assignment of isotope labels will be utilized for both apheresis collections for the same subject in Stage 1 After radiolabeling the autologous Control and Test platelet samples will be simultaneously infused into the subject approximately 10 30 mL A negative pregnancy test for females of childbearing potential is required before infusion
Blood samples will be drawn immediately before infusion and for radioactivity measurements at 1 hour 15 min and 2 hours 15 min post-infusion Day 0 and 6 more samples will be drawn at 1 2 3 4 or 5 or 6 7 or 8 and 111 days post-infusion DPI at approximately the same time of day as the radiolabeled platelet infusion was administered 4 hours The exact time of each sample draw will be recorded
For subjects enrolled in Stage 1 there will be a minimum washout period of four weeks between the two study periods eg four weeks after the last blood sample at 111 DPI in Period 1 Subjects will be monitored for safety adverse events from the first apheresis procedure until 24 hours after the last DPI blood sample is drawn
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None