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| Name | Class |
|---|---|
| American National Red Cross | OTHER |
The rationale for a Treatment Use Investigational Device Exemption (IDE) of INTERCEPT PCs is to address current gaps in platelet transfusion safety in selected geographic regions. The objective is to provide access to INTERCEPT PCs for patients who might be at risk of transfusion-transmitted infection (TTI) due to Chikungunya virus (CHIKV) and Dengue virus (DENV) in regions in which a substantial proportion of the population has been infected or is at risk of infection by these pathogens (Petersen 2014); and the risk of asymptomatic infection among qualified blood donors is recognized (Stramer 2012, Adda 2014).
The study is designed as a prospective, open label, multi-center, observational study to evaluate the safety and efficacy of INTERCEPT platelet components.
Upon written informed consent, patients will be transfused with study PCs according to local practices. Each patient will be supported with platelets as clinically indicated in a manner that is consistent with the local standard of care. The study will be conducted in two phases. During the pilot phase, patients will sign informed consent to have study data collected following transfusion with conventional PCs. The objective of the pilot phase is to evaluate study logistics and data collection methods. During the INTERCEPT Treatment Use phase, patients will sign informed consent to receive INTERCEPT PCs, provide blood samples, and collect study data (demographics, transfusion data, and safety data).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INTERCEPT Platelets | Biological | INTERCEPT platelet components (PC). Leukocyte reduced apheresis platelet components collected in Platelet Additive Solution (PAS) or 100% plasma without gamma irradiation, bacterial detection, and Cytomegalovirus (CMV) serology testing. |
| Measure | Description | Time Frame |
|---|---|---|
| The Proportion of Transfused INTERCEPT Platelet Components With a Post-treatment Platelet Dose ≥ 3.0×10^11 Platelets. | INTERCEPT platelet components (PCs) manufactured for this study are leukocyte reduced apheresis PCs processed using the INTERCEPT Blood System (IBS) for platelets. The IBS for platelets is a Class III medical device approved by the FDA for the ex-vivo preparation and storage of pathogen reduced apheresis PCs. The system is used to inactivate a broad range of pathogens, including viruses, bacteria, and protozoan parasites as well as contaminating donor leukocytes. Post-manufacturing, INTERCEPT PCs are either transfused or stored according to blood center standard operating procedures, US FDA, and AABB Guidelines. Subjects enrolled in this study are transfused with INTERCEPT PCs as dictated by the treating physician. One platelet component was treated as one platelet transfusion for the purpose of data analysis in this study. | 1 year |
| The Proportion of Patients With a Confirmed Case of Transfusion-transmitted Chikungunya Virus or Dengue Infection | 1 year | |
| The Proportion of Patients With Any Transfusion Reactions | Transfusion reactions are defined as adverse events assessed as possibly, likely/probably or certainly related to the INTERCEPT platelet component transfused. | 1 year |
| The Proportion of Patients With Any Unrelated Adverse Event | Unrelated adverse events are defined as adverse events unrelated to the INTERCEPT platelet component transfused. | 1 year |
| The Proportion of Transfused INTERCEPT Platelet Components Associated With Any Transfusion Reactions and/or Unrelated Adverse Event | Transfusion reactions are defined as adverse events assessed as possibly, likely/probably or certainly related to the INTERCEPT platelet component transfused. Unrelated adverse events are defined as adverse events unrelated to the INTERCEPT platelet component transfused. ""1 Transfusion = 1 Intercept Platelet Component". |
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Inclusion Criteria:
Exclusion Criteria
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Patients requiring a platelet transfusion.
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| Name | Affiliation | Role |
|---|---|---|
| Susan L Stramer, PhD | American National Red Cross | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General Menonita de Aibonito | Aibonito | 00705 | Puerto Rico | |||
| Hospital General Menonita de Caguas |
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| ID | Title | Description |
|---|---|---|
| FG000 | INTERCEPT | Includes patients enrolled during the INTERCEPT-Treatment-Use phase of the study who received at least one INTERCEPT platelet component. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 1 year |
| Caguas |
| 00725 |
| Puerto Rico |
| Hospital General Menonita de Cayey | Cayey | Puerto Rico |
| Center Hospital Manati | Manati | 00674 | Puerto Rico |
| Hospital San Lucas Ponce | Ponce | 00733 | Puerto Rico |
| Hospital La Concepcion San German | San German | 00683 | Puerto Rico |
| Centro Cardiovascular de Puerto Rico and the Caribbean | San Juan | 00683 | Puerto Rico |
| Veteran Administration | San Juan | 00921 | Puerto Rico |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | INTERCEPT | Includes patients enrolled during the INTERCEPT-Treatment-Use phase of the study who received at least one INTERCEPT platelet component. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Proportion of Transfused INTERCEPT Platelet Components With a Post-treatment Platelet Dose ≥ 3.0×10^11 Platelets. | INTERCEPT platelet components (PCs) manufactured for this study are leukocyte reduced apheresis PCs processed using the INTERCEPT Blood System (IBS) for platelets. The IBS for platelets is a Class III medical device approved by the FDA for the ex-vivo preparation and storage of pathogen reduced apheresis PCs. The system is used to inactivate a broad range of pathogens, including viruses, bacteria, and protozoan parasites as well as contaminating donor leukocytes. Post-manufacturing, INTERCEPT PCs are either transfused or stored according to blood center standard operating procedures, US FDA, and AABB Guidelines. Subjects enrolled in this study are transfused with INTERCEPT PCs as dictated by the treating physician. One platelet component was treated as one platelet transfusion for the purpose of data analysis in this study. | This outcome summarizes the 256 INTERCEPT platelet components transfused during the INTERCEPT-Treatment-Use phase of the study. A total of 90 patients received at least one INTERCEPT platelet component. "1 Transfusion = 1 Intercept Platelet Component". | Posted | Count of Units | Platelet Components | 1 year | Platelet Components | Platelet Components |
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| Primary | The Proportion of Patients With a Confirmed Case of Transfusion-transmitted Chikungunya Virus or Dengue Infection | Posted | Count of Participants | Participants | 1 year |
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| Primary | The Proportion of Patients With Any Transfusion Reactions | Transfusion reactions are defined as adverse events assessed as possibly, likely/probably or certainly related to the INTERCEPT platelet component transfused. | Posted | Count of Participants | Participants | 1 year |
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| Primary | The Proportion of Patients With Any Unrelated Adverse Event | Unrelated adverse events are defined as adverse events unrelated to the INTERCEPT platelet component transfused. | Posted | Count of Participants | Participants | 1 year |
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| Primary | The Proportion of Transfused INTERCEPT Platelet Components Associated With Any Transfusion Reactions and/or Unrelated Adverse Event | Transfusion reactions are defined as adverse events assessed as possibly, likely/probably or certainly related to the INTERCEPT platelet component transfused. Unrelated adverse events are defined as adverse events unrelated to the INTERCEPT platelet component transfused. ""1 Transfusion = 1 Intercept Platelet Component". | This outcome summarizes the 256 INTERCEPT platelet components transfused during the INTERCEPT-Treatment-Use phase of the study. A total of 90 patients received at least one INTERCEPT platelet component. | Posted | Count of Units | Platelet Components | 1 year | Platelet Components | Platelet Components |
|
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Adverse event data were collected for 24 hours following each study transfusion and serious adverse event data were collected for 7 days post each study transfusion.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | INTERCEPT | Includes patients enrolled during the INTERCEPT-Treatment-Use phase of the study who received at least one INTERCEPT platelet component. | 17 | 90 | 19 | 90 | 15 | 90 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | Systematic Assessment |
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| Cardio-respiratory arrest | Cardiac disorders | Systematic Assessment |
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| Cardiogenic shock | Cardiac disorders | Systematic Assessment |
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| Rectal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
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| Multi-organ failure | General disorders | Systematic Assessment |
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| Hepatorenal syndrome | Hepatobiliary disorders | Systematic Assessment |
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| Klebsiella bacteraemia | Infections and infestations | Systematic Assessment |
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| Pneumonia | Infections and infestations | Systematic Assessment |
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| Sepsis | Infections and infestations | Systematic Assessment |
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| Septic shock | Infections and infestations | Systematic Assessment |
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| Acute leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Brain injury | Nervous system disorders | Systematic Assessment |
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| Hepatic encephalopathy | Nervous system disorders | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | Systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Choking | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Vena cava thrombosis | Vascular disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Malaise | General disorders | Systematic Assessment |
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| Oedema | General disorders | Systematic Assessment |
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| Pyrexia | General disorders | Systematic Assessment |
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| Blood pressure decreased | Investigations | Systematic Assessment |
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| Haemoglobin decreased | Investigations | Systematic Assessment |
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| Heart rate increased | Investigations | Systematic Assessment |
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| HIV test positive | Investigations | Systematic Assessment |
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| Convulsion | Nervous system disorders | Systematic Assessment |
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| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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| Hypotension | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carol Moore, Senior VP Regulatory Affairs & Quality | Cerus | 925-288-6361 | cmoore@cerus.com |
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| Title | Denominators | Categories |
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| Denominators |
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| Categories |
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| Platelet Components |
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