Trial Outcomes & Findings for Retrospective Data Collection of Routine Use With Spectra Optia® for Platelet Depletions (NCT NCT02308787)

NCT ID: NCT02308787

Last Updated: 2016-06-15

Results Overview

(PLTpre - PLTpost) / PLTpre x 100%

• Recruitment status: COMPLETED
• Target enrollment: 12 participants
• Primary outcome timeframe: on average this will be within 15 minutes after the end of the procedure
• Results posted on: 2016-06-15

Participant Flow

Participant milestones

Measure	Subjects Who Received a Minimum of 1 PLTD Procedure u Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Retrospective Data Collection of Routine Use With Spectra Optia® for Platelet Depletions

Baseline characteristics by cohort

Measure	Subjects Who Received a Minimum of 1 PLTD Procedure u n=12 Participants Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
Age, Customized Age (years)	64.3 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment Denmark	3 participants n=5 Participants
Region of Enrollment Hungary	9 participants n=5 Participants
Weight	63.6 kg STANDARD_DEVIATION 13.4 • n=5 Participants
Height	163.9 cm STANDARD_DEVIATION 9.2 • n=5 Participants
Total Blood Volume	4.0 Liters STANDARD_DEVIATION 0.7 • n=5 Participants
Diagnosis Essential thrombocythaemia	9 pariticpants n=5 Participants
Diagnosis Chronic myeloid leukaemia	1 pariticpants n=5 Participants
Diagnosis Myelodysplastic/myeloproliferative neoplasm	1 pariticpants n=5 Participants
Diagnosis Polycythaemia vera	1 pariticpants n=5 Participants

PRIMARY outcome

Timeframe: on average this will be within 15 minutes after the end of the procedure

Population: Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.

(PLTpre - PLTpost) / PLTpre x 100%

Outcome measures

Measure	Subjects Who Received a Minimum of 1 PLTD Procedure u n=20 procedures Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
Percent Change in Platelet (PLT) Count in Patient Blood Following Apheresis Procedure	-58.2 % change in PLT count in subject blood Standard Deviation 12.0

PRIMARY outcome

Timeframe: on average this will be within 15 minutes after the end of the procedure

Population: At Site 2, percent processed platelets could only be calculated for 1 procedure in Subject 214; no waste bag (depletion product) platelet counts were available for the other 9 procedures performed at Site 2.

(PLT/µL product x product volume) / ((PLTpre + PLTpost) / 2) x total processed blood volume)

Outcome measures

Measure	Subjects Who Received a Minimum of 1 PLTD Procedure u n=11 Procedures Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
Percent of Processed Platelets (PLT) Which Are Collected i.e. Collection Efficiency for Platelets Achieved by Spectra Optia.	67.8 % of processed platelets Standard Deviation 18.3

PRIMARY outcome

Timeframe: during the apheresis procedure (from the moment the patient is connected until he is disconnected from the device) and device or procedure related adverse events until discharge from Apheresis Unit (On average, half hour after end of procedure).

Population: Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.

Outcome measures

Measure	Subjects Who Received a Minimum of 1 PLTD Procedure u n=12 Participants Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
Adverse Events	6 Number of subjects with at least 1 AE

OTHER_PRE_SPECIFIED outcome

Timeframe: Prior to each Spectra Optia Apheresis Procedure

Population: Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.

Outcome measures

Measure	Subjects Who Received a Minimum of 1 PLTD Procedure u n=20 procedures Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
Patient's Platelet Count Pre-depletion Procedure	1740.7 cells x 10^3/L Standard Deviation 744.95

OTHER_PRE_SPECIFIED outcome

Timeframe: Participants were followed for the duration of the procedure and an average of 2.5 hours after the procedure

Population: Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.

Outcome measures

Measure	Subjects Who Received a Minimum of 1 PLTD Procedure u n=20 procedures Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
Patient's Platelet Count Post-depletion Procedure	717.2 cells x 10^3/L Standard Deviation 336

OTHER_PRE_SPECIFIED outcome

Timeframe: Prior to each Spectra Optia Apheresis Procedure

Outcome measures

Measure	Subjects Who Received a Minimum of 1 PLTD Procedure u n=20 procedures Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
Patients WBC Count Pre-depletion Procedure	15.9 cells x 10^9/L Standard Deviation 18.29

OTHER_PRE_SPECIFIED outcome

Timeframe: Participants were followed for the duration of the procedure and an average of 2.5 hours after the procedure

Population: Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.

Outcome measures

Measure	Subjects Who Received a Minimum of 1 PLTD Procedure u n=20 procedures Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
Patient's WBC Count Post-depletion Procedure	8.4 cells x 10^9/L Standard Deviation 6.66

OTHER_PRE_SPECIFIED outcome

Timeframe: Post each Spectra Optia Apheresis Procedure

Population: Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.

Volume of patients blood processed during the apheresis procedure.

Outcome measures

Measure	Subjects Who Received a Minimum of 1 PLTD Procedure u n=20 procedures Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
Whole Blood Processed (mL)	6652.3 mL Standard Deviation 856.42

OTHER_PRE_SPECIFIED outcome

Timeframe: Participants were followed for the duration of the procedure and an average of 2.5 hours after the procedure

Population: Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.

Outcome measures

Measure	Subjects Who Received a Minimum of 1 PLTD Procedure u n=20 procedures Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
Average Inlet Flow Rate	46.7 mL/min Standard Deviation 8.45

OTHER_PRE_SPECIFIED outcome

Timeframe: Participants were followed for the duration of the procedure and an average of 2.5 hours after the procedure

Population: Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.

Outcome measures

Measure	Subjects Who Received a Minimum of 1 PLTD Procedure u n=20 procedures Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
Procedure Duration	144.5 minutes Standard Deviation 17.81

OTHER_PRE_SPECIFIED outcome

Timeframe: Post each Spectra Optia Apheresis Procedure

Population: Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.

Outcome measures

Measure	Subjects Who Received a Minimum of 1 PLTD Procedure u n=20 procedures Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
Waste Bag Volume	669.8 mL Standard Deviation 248.48

OTHER_PRE_SPECIFIED outcome

Timeframe: Post each Spectra Optia Apheresis Procedure

Population: Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.

The number of times the patient's total blood volume is processed during the apheresis procedure.

Outcome measures

Measure	Subjects Who Received a Minimum of 1 PLTD Procedure u n=20 procedures Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
Total Blood Volume (TBV) Processed	1.7 Number of TBVs processed Standard Deviation 0.25

Adverse Events

Subjects Who Received a Minimum of 1 PLTD Procedure u

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Subjects Who Received a Minimum of 1 PLTD Procedure u n=12 participants at risk Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
Blood and lymphatic system disorders Anemia	25.0% 3/12 • Adverse event (AE) data (including serious adverse events [SAEs]) were collected from the time of the start of the PLTD procedure until discharge from the Apheresis Unit. Adverse events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, and coded using the Medical Dictionary for Regulatory Activities (MedDRA®, Version 17.0).
Vascular disorders Hypotension	25.0% 3/12 • Adverse event (AE) data (including serious adverse events [SAEs]) were collected from the time of the start of the PLTD procedure until discharge from the Apheresis Unit. Adverse events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, and coded using the Medical Dictionary for Regulatory Activities (MedDRA®, Version 17.0).
Nervous system disorders Dizziness	8.3% 1/12 • Adverse event (AE) data (including serious adverse events [SAEs]) were collected from the time of the start of the PLTD procedure until discharge from the Apheresis Unit. Adverse events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, and coded using the Medical Dictionary for Regulatory Activities (MedDRA®, Version 17.0).
General disorders Malaise	8.3% 1/12 • Adverse event (AE) data (including serious adverse events [SAEs]) were collected from the time of the start of the PLTD procedure until discharge from the Apheresis Unit. Adverse events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, and coded using the Medical Dictionary for Regulatory Activities (MedDRA®, Version 17.0).
Investigations White blood cell count decreased	8.3% 1/12 • Adverse event (AE) data (including serious adverse events [SAEs]) were collected from the time of the start of the PLTD procedure until discharge from the Apheresis Unit. Adverse events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, and coded using the Medical Dictionary for Regulatory Activities (MedDRA®, Version 17.0).

Additional Information

Raymond P. Goodrich, PhD, VP, Scientific and Clinical Affairs; Chief Science Officer-BBT

Terumo BCT

Phone: (303) 231-4357

Email: Ray.Goodrich@terumobct.com

Results disclosure agreements

• Principal investigator is a sponsor employee Study Site reserves the right to publish the results of its work on the Study. Study Site and the PI agree to submit copies of any manuscript/abstract proposed for publication to Sponsor at least 30 days in advance of the presentation. Sponsor may require the delay of publication for no longer than 90 days for the purpose of filing patent applications.
• Publication restrictions are in place

Restriction type: OTHER