Trial Outcomes & Findings for COMPACT 2 - COMbining Plasma-filtration and Adsorption Clinical Trial 2 (NCT NCT01639664)

Last Updated: 2021-09-05

Results Overview

For patients discharged to other hospital, it will be intended as mortality at the discharge from the latest hospital in which the patients stayed.

Recruitment status

TERMINATED

Study phase

Target enrollment

115 participants

Primary outcome timeframe

At the discharge from the latest hospital (on average 30.3 days)

Results posted on

2021-09-05

Participant Flow

The interim analysis requested by the EDSMC shows higher mortality for the CPFA group compared to the controls, particularly in the first days of treatment. This result raise concern that the use of CPFA may cause harm or worsen the clinical condition of septic shock patients. For this reason we did not conclude the participant enrollment of the study. The COMPACT-2 study has been prematurely terminated as from 23/10/2017.

Participant milestones

Participant milestones
Measure	High Doses CPFA High doses CPFA (coupled plasma-filtration adsorption) with AMPLYA™ (BELLCO ITALY): \>0.20 L/kg/day of plasma treated in the first 3 days after randomization and on each of the subsequent days in which the patient is still in septic-shock condition.	Control Group standard practice
Overall Study STARTED	63	52
Overall Study COMPLETED	63	52
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High Doses CPFA n=63 Participants High doses CPFA (coupled plasma-filtration adsorption) with AMPLYA™ (BELLCO ITALY): \>0.20 L/kg/day of plasma treated in the first 3 days after randomization.	Control Group n=52 Participants Standard practice	Total n=115 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=63 Participants	0 Participants n=52 Participants	0 Participants n=115 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=63 Participants	20 Participants n=52 Participants	44 Participants n=115 Participants
Age, Categorical >=65 years	39 Participants n=63 Participants	32 Participants n=52 Participants	71 Participants n=115 Participants
Age, Continuous	66.9 years STANDARD_DEVIATION 13.8 • n=63 Participants	67.0 years STANDARD_DEVIATION 10.5 • n=52 Participants	67.0 years STANDARD_DEVIATION 12.4 • n=115 Participants
Sex: Female, Male Female	23 Participants n=63 Participants	24 Participants n=52 Participants	47 Participants n=115 Participants
Sex: Female, Male Male	40 Participants n=63 Participants	28 Participants n=52 Participants	68 Participants n=115 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Italy	63 participants n=63 Participants	52 participants n=52 Participants	115 participants n=115 Participants
Length of stay before ICU admission	4.0 days STANDARD_DEVIATION 7.2 • n=63 Participants	3.0 days STANDARD_DEVIATION 5.2 • n=52 Participants	3.6 days STANDARD_DEVIATION 6.4 • n=115 Participants
SAPS II	60 units on a scale n=63 Participants	55 units on a scale n=52 Participants	57.5 units on a scale n=115 Participants
Septic shock on admission	45 Participants n=63 Participants	40 Participants n=52 Participants	85 Participants n=115 Participants

PRIMARY outcome

Timeframe: At the discharge from the latest hospital (on average 30.3 days)

For patients discharged to other hospital, it will be intended as mortality at the discharge from the latest hospital in which the patients stayed.

Outcome measures

Outcome measures
Measure	High Doses CPFA n=63 Participants High doses CPFA (coupled plasma-filtration adsorption) with AMPLYA™ (BELLCO ITALY): \>0.20 L/kg/day of plasma treated in the first 3 days after randomization.	Control n=52 Participants Standard practice
Hospital Mortality	35 Participants	24 Participants

SECONDARY outcome

Timeframe: 90 days from randomization

Population: 11 patients lost at the follow-up

Outcome measures

Outcome measures
Measure	High Doses CPFA n=56 Participants High doses CPFA (coupled plasma-filtration adsorption) with AMPLYA™ (BELLCO ITALY): \>0.20 L/kg/day of plasma treated in the first 3 days after randomization.	Control n=48 Participants Standard practice
Mortality Within 90 Days From Randomization	36 Participants	25 Participants

SECONDARY outcome

Timeframe: 30 days from randomization

Outcome measures

Outcome measures
Measure	High Doses CPFA n=63 Participants High doses CPFA (coupled plasma-filtration adsorption) with AMPLYA™ (BELLCO ITALY): \>0.20 L/kg/day of plasma treated in the first 3 days after randomization.	Control n=52 Participants Standard practice
ICU LOS Reduction Measured as Days Not Spent in the ICU During the First 30 Days From Randomization	6.6 days Standard Deviation 9.7	9.3 days Standard Deviation 9.9

SECONDARY outcome

Timeframe: 15 days from randomization

Outcome measures

Outcome data not reported

Adverse Events

High Doses CPFA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 36 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 25 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Guido Bertolini

Istituto di Ricerche Farmacologiche Mario Negri IRCCS

Phone: 035 4535 313

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place