Trial Outcomes & Findings for A Prospective, Open Label, Treatment Use Study of Patient Safety Following Transfusion of INTERCEPT Platelet Components (NCT NCT02305732)

Last Updated: 2018-10-30

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

90 participants

Primary outcome timeframe

1 year

Results posted on

2018-10-30

Participant Flow

Participant milestones

Participant milestones
Measure	INTERCEPT Includes patients enrolled during the INTERCEPT-Treatment-Use phase of the study who received at least one INTERCEPT platelet component.
Overall Study STARTED	90
Overall Study COMPLETED	72
Overall Study NOT COMPLETED	18

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Prospective, Open Label, Treatment Use Study of Patient Safety Following Transfusion of INTERCEPT Platelet Components

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	INTERCEPT n=90 Participants Includes patients enrolled during the INTERCEPT-Treatment-Use phase of the study who received at least one INTERCEPT platelet component.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=5 Participants
Age, Categorical >=65 years	59 Participants n=5 Participants
Age, Continuous	67.2 Years STANDARD_DEVIATION 15.8 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants
Sex: Female, Male Male	50 Participants n=5 Participants
Region of Enrollment Puerto Rico	90 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: 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".

Outcome measures

Outcome measures
Measure	Transfused INTERCEPT Components n=256 Platelet Components Includes all INTERCEPT platelet components transfused during the INTERCEPT-Treatment-Use phase of the study.
The Proportion of Transfused INTERCEPT Platelet Components With a Post-treatment Platelet Dose ≥ 3.0×10^11 Platelets.	256 Platelet Components

PRIMARY outcome

Timeframe: 1 year

Outcome measures

Outcome measures
Measure	Transfused INTERCEPT Components n=90 Participants Includes all INTERCEPT platelet components transfused during the INTERCEPT-Treatment-Use phase of the study.
The Proportion of Patients With a Confirmed Case of Transfusion-transmitted Chikungunya Virus or Dengue Infection	0 Participants

PRIMARY outcome

Timeframe: 1 year

Transfusion reactions are defined as adverse events assessed as possibly, likely/probably or certainly related to the INTERCEPT platelet component transfused.

Outcome measures

Outcome measures
Measure	Transfused INTERCEPT Components n=90 Participants Includes all INTERCEPT platelet components transfused during the INTERCEPT-Treatment-Use phase of the study.
The Proportion of Patients With Any Transfusion Reactions	3 Participants

PRIMARY outcome

Timeframe: 1 year

Unrelated adverse events are defined as adverse events unrelated to the INTERCEPT platelet component transfused.

Outcome measures

Outcome measures
Measure	Transfused INTERCEPT Components n=90 Participants Includes all INTERCEPT platelet components transfused during the INTERCEPT-Treatment-Use phase of the study.
The Proportion of Patients With Any Unrelated Adverse Event	26 Participants

PRIMARY outcome

Timeframe: 1 year

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".

Outcome measures

Outcome measures
Measure	Transfused INTERCEPT Components n=256 Platelet Components Includes all INTERCEPT platelet components transfused during the INTERCEPT-Treatment-Use phase of the study.
The Proportion of Transfused INTERCEPT Platelet Components Associated With Any Transfusion Reactions and/or Unrelated Adverse Event	50 Platelet Components

Adverse Events

INTERCEPT

Serious events: 19 serious events

Other events: 15 other events

Deaths: 17 deaths

Serious adverse events

Serious adverse events
Measure	INTERCEPT n=90 participants at risk Includes patients enrolled during the INTERCEPT-Treatment-Use phase of the study who received at least one INTERCEPT platelet component.
Blood and lymphatic system disorders Disseminated intravascular coagulation	1.1% 1/90 • Number of events 1 • 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.
Cardiac disorders Cardiac failure	1.1% 1/90 • Number of events 1 • 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.
Cardiac disorders Cardio-respiratory arrest	2.2% 2/90 • Number of events 2 • 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.
Cardiac disorders Cardiogenic shock	1.1% 1/90 • Number of events 1 • 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.
Gastrointestinal disorders Rectal haemorrhage	1.1% 1/90 • Number of events 1 • 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.
General disorders Multi-organ failure	1.1% 1/90 • Number of events 1 • 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.
Hepatobiliary disorders Hepatorenal syndrome	1.1% 1/90 • Number of events 1 • 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.
Infections and infestations Klebsiella bacteraemia	1.1% 1/90 • Number of events 1 • 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.
Infections and infestations Pneumonia	1.1% 1/90 • Number of events 1 • 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.
Infections and infestations Sepsis	1.1% 1/90 • Number of events 1 • 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.
Infections and infestations Septic shock	6.7% 6/90 • Number of events 6 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute leukaemia	1.1% 1/90 • Number of events 1 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	1.1% 1/90 • Number of events 1 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	1.1% 1/90 • Number of events 1 • 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.
Nervous system disorders Brain injury	1.1% 1/90 • Number of events 1 • 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.
Nervous system disorders Hepatic encephalopathy	1.1% 1/90 • Number of events 1 • 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.
Renal and urinary disorders Renal failure	1.1% 1/90 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	2.2% 2/90 • Number of events 2 • 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.
Respiratory, thoracic and mediastinal disorders Choking	1.1% 1/90 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Respiratory failure	3.3% 3/90 • Number of events 3 • 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.
Vascular disorders Vena cava thrombosis	1.1% 1/90 • Number of events 1 • 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.

Other adverse events

Other adverse events
Measure	INTERCEPT n=90 participants at risk Includes patients enrolled during the INTERCEPT-Treatment-Use phase of the study who received at least one INTERCEPT platelet component.
Blood and lymphatic system disorders Febrile neutropenia	2.2% 2/90 • Number of events 2 • 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.
Gastrointestinal disorders Nausea	1.1% 1/90 • Number of events 1 • 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.
Gastrointestinal disorders Vomiting	1.1% 1/90 • Number of events 1 • 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.
General disorders Malaise	1.1% 1/90 • Number of events 1 • 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.
General disorders Oedema	1.1% 1/90 • Number of events 1 • 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.
General disorders Pyrexia	1.1% 1/90 • Number of events 1 • 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.
Investigations Blood pressure decreased	2.2% 2/90 • Number of events 2 • 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.
Investigations Haemoglobin decreased	1.1% 1/90 • Number of events 1 • 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.
Investigations Heart rate increased	1.1% 1/90 • Number of events 1 • 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.
Investigations HIV test positive	1.1% 1/90 • Number of events 1 • 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.
Nervous system disorders Convulsion	1.1% 1/90 • Number of events 1 • 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.
Psychiatric disorders Anxiety	1.1% 1/90 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.1% 1/90 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders Erythema	1.1% 1/90 • Number of events 1 • 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.
Vascular disorders Hypertension	2.2% 2/90 • Number of events 2 • 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.
Vascular disorders Hypotension	3.3% 3/90 • Number of events 3 • 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.

Additional Information

Carol Moore, Senior VP Regulatory Affairs & Quality

Cerus

Phone: 925-288-6361

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place