Trial Outcomes & Findings for Markers of Inflammation and Lung Recovery in ECMO Patients for PPHN (NCT NCT02940327)

NCT ID: NCT02940327

Last Updated: 2020-03-19

Results Overview

Change of markers of platelet and leukocyte activation in arterial blood and analysed by flow cytometry.

• Recruitment status: COMPLETED
• Target enrollment: 24 participants
• Primary outcome timeframe: 12 hours after ECMO commencement
• Results posted on: 2020-03-19

Participant Flow

Participant milestones

Measure	1 - Observational Case-Controls Observational Case-Controls.
Overall Study STARTED	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Markers of Inflammation and Lung Recovery in ECMO Patients for PPHN

Baseline characteristics by cohort

Measure	1 - Observational Case-Controls n=24 Participants Observational Case-Controls.
Age, Categorical <=18 years	24 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Gestational age	40.6 weeks STANDARD_DEVIATION 2.6 • n=5 Participants
Weight at birth	3.2 kilograms n=5 Participants

PRIMARY outcome

Timeframe: 12 hours after ECMO commencement

Change of markers of platelet and leukocyte activation in arterial blood and analysed by flow cytometry.

Outcome measures

Measure	7+ Days n=10 Participants on ECMO	<7 Days n=14 Participants on ECMO
CD16/41	1.90 percent change Standard Deviation 3.52	1.13 percent change Standard Deviation 3.03

PRIMARY outcome

Timeframe: 24 hours after ECMO commencement

Change of markers of platelet and leukocyte activation in arterial blood and analysed by flow cytometry.

Outcome measures

Measure	7+ Days n=10 Participants on ECMO	<7 Days n=14 Participants on ECMO
CD16/41	3.11 percentage change Standard Deviation 1.9	0.64 percentage change Standard Deviation 3.26

PRIMARY outcome

Timeframe: 48 hours after ECMO commencement

Change of markers of platelet and leukocyte activation in arterial blood and analysed by flow cytometry.

Outcome measures

Measure	7+ Days n=10 Participants on ECMO	<7 Days n=12 Participants on ECMO
CD16/41	0.73 percentage change Standard Deviation 3.86	0.4 percentage change Standard Deviation 4.3

PRIMARY outcome

Timeframe: 72 hours after ECMO commencement

Change of markers of platelet and leukocyte activation in arterial blood and analysed by flow cytometry.

Outcome measures

Measure	7+ Days n=10 Participants on ECMO	<7 Days n=8 Participants on ECMO
CD16/41	1.55 percentage change Standard Deviation 3.37	0.93 percentage change Standard Deviation 1.99

PRIMARY outcome

Timeframe: 24 hours after decannulation

Change of markers of platelet and leukocyte activation in arterial blood and analysed by flow cytometry.

Outcome measures

Measure	7+ Days n=7 Participants on ECMO	<7 Days n=12 Participants on ECMO
CD16/41	1.56 percentage change Standard Deviation 2.27	0.6 percentage change Standard Deviation 3.98

PRIMARY outcome

Timeframe: 12 hours after ECMO commencement

Change of markers of platelet and leukocyte activation in arterial blood and analysed by flow cytometry.

Outcome measures

Measure	7+ Days n=10 Participants on ECMO	<7 Days n=14 Participants on ECMO
CD14/41	1.5 percentage change Standard Deviation 3.37	0.84 percentage change Standard Deviation 2.97

PRIMARY outcome

Timeframe: 24 hours after ECMO commencement

Change of markers of platelet and leukocyte activation in arterial blood and analysed by flow cytometry.

Outcome measures

Measure	7+ Days n=10 Participants on ECMO	<7 Days n=14 Participants on ECMO
CD14/41	3.02 percentage change Standard Deviation 2.39	0.38 percentage change Standard Deviation 3.48

PRIMARY outcome

Timeframe: 48 hours after ECMO commencement

Change of markers of platelet and leukocyte activation in arterial blood and analysed by flow cytometry.

Outcome measures

Measure	7+ Days n=10 Participants on ECMO	<7 Days n=12 Participants on ECMO
CD14/41	0.29 percentage change Standard Deviation 4.51	0.27 percentage change Standard Deviation 5.78

PRIMARY outcome

Timeframe: 72 hours after ECMO commencement

Change of markers of platelet and leukocyte activation in arterial blood and analysed by flow cytometry.

Outcome measures

Measure	7+ Days n=10 Participants on ECMO	<7 Days n=8 Participants on ECMO
CD14/41	0.72 percentage change Standard Deviation 4.65	0.59 percentage change Standard Deviation 2.73

PRIMARY outcome

Timeframe: 24 hours after ECMO decannulation

Change of markers of platelet and leukocyte activation in arterial blood and analysed by flow cytometry.

Outcome measures

Measure	7+ Days n=7 Participants on ECMO	<7 Days n=12 Participants on ECMO
CD14/41	1.01 percentage change Standard Deviation 3.03	0.40 percentage change Standard Deviation 4.58

PRIMARY outcome

Timeframe: 12 hours after ECMO commencement

Change of markers of platelet and leukocyte activation in arterial blood and analysed by flow cytometry.

Outcome measures

Measure	7+ Days n=10 Participants on ECMO	<7 Days n=14 Participants on ECMO
CD64/163	8.7 percentage change Standard Deviation 2.52	4.65 percentage change Standard Deviation 2.81

PRIMARY outcome

Timeframe: 24 hours after ECMO commencement

Change of markers of platelet and leukocyte activation in arterial blood and analysed by flow cytometry.

Outcome measures

Measure	7+ Days n=10 Participants on ECMO	<7 Days n=14 Participants on ECMO
CD64/163	7.34 percentage change Standard Deviation 5.13	1.89 percentage change Standard Deviation 5.87

PRIMARY outcome

Timeframe: 48 hours after ECMO commencement

Change of markers of platelet and leukocyte activation in arterial blood and analysed by flow cytometry.

Outcome measures

Measure	7+ Days n=10 Participants on ECMO	<7 Days n=12 Participants on ECMO
CD64/163	3.26 percentage change Standard Deviation 4.15	0.92 percentage change Standard Deviation 2.52

PRIMARY outcome

Timeframe: 72 hours after ECMO commencement

Change of markers of platelet and leukocyte activation in arterial blood and analysed by flow cytometry.

Outcome measures

Measure	7+ Days n=10 Participants on ECMO	<7 Days n=8 Participants on ECMO
CD64/163	3.31 percentage change Standard Deviation 3.39	1.9 percentage change Standard Deviation 3.86

PRIMARY outcome

Timeframe: 24 hours after decannulation

Change of markers of platelet and leukocyte activation in arterial blood and analysed by flow cytometry.

Outcome measures

Measure	7+ Days n=7 Participants on ECMO	<7 Days n=12 Participants on ECMO
CD64/163	3.2 percentage change Standard Deviation 3.55	2.27 percentage change Standard Deviation 2.89

SECONDARY outcome

Timeframe: baseline

Clinical and biochemical markers of organ failure

Outcome measures

Measure	7+ Days n=10 Participants on ECMO	<7 Days n=14 Participants on ECMO
Change of Serum Haemoglobin Levels	151.5 g/L Standard Deviation 33.0	145.4 g/L Standard Deviation 41.5

SECONDARY outcome

Timeframe: > 7 days or did not survive to discharge

Clinical and biochemical markers of organ failure

Outcome measures

Measure	7+ Days n=10 Participants on ECMO	<7 Days n=14 Participants on ECMO
Duration on ECMO	292 hours Interval 186.0 to 360.0	80 hours Interval 59.0 to 91.0

SECONDARY outcome

Timeframe: >7 days or did not survive to discharge

Clinical and biochemical markers of organ failure

Outcome measures

Measure	7+ Days n=10 Participants on ECMO	<7 Days n=14 Participants on ECMO
Number of Participants With Acute Kidney Injury	3 participants	0 participants

SECONDARY outcome

Timeframe: 12 hours after ECMO commencement

Clinical and biochemical markers of organ failure

Outcome measures

Measure	7+ Days n=10 Participants on ECMO	<7 Days n=14 Participants on ECMO
Heart Injury as Determined by Serum Troponin Levels	7.89 ng/ml Standard Deviation 1.17	6.96 ng/ml Standard Deviation 1.14

SECONDARY outcome

Timeframe: 24 hours after ECMO is discontinued

Clinical and biochemical markers of organ failure

Outcome measures

Measure	7+ Days n=10 Participants on ECMO	<7 Days n=14 Participants on ECMO
Allogenic Red Cell Transfusion Volume	289.6 ml Standard Deviation 241.0	479.2 ml Standard Deviation 268.2

SECONDARY outcome

Timeframe: 24 hours after ECMO is discontinued

Clinical and biochemical markers of organ failure

Outcome measures

Measure	7+ Days n=10 Participants on ECMO	<7 Days n=14 Participants on ECMO
Number of Participants Requiring Non Red Cell Transfusion	10 Participants	10 Participants

SECONDARY outcome

Timeframe: 24 hours after ECMO commencement

Clinical and biochemical markers of organ failure

Outcome measures

Measure	7+ Days n=10 Participants on ECMO	<7 Days n=14 Participants on ECMO
Heart Injury as Determined by Serum Troponin Levels	3.71 ng/ml Standard Deviation 1.54	3.11 ng/ml Standard Deviation 1.62

SECONDARY outcome

Timeframe: 48 hours after ECMO commencement

Clinical and biochemical markers of organ failure

Outcome measures

Measure	7+ Days n=10 Participants on ECMO	<7 Days n=12 Participants on ECMO
Heart Injury as Determined by Serum Troponin Levels	2.13 ng/ml Standard Deviation 1.14	1.81 ng/ml Standard Deviation 1.28

SECONDARY outcome

Timeframe: 72 hours after ECMO commencement

Clinical and biochemical markers of organ failure

Outcome measures

Measure	7+ Days n=10 Participants on ECMO	<7 Days n=8 Participants on ECMO
Heart Injury as Determined by Serum Troponin Levels	5.51 ng/ml Standard Deviation 2.03	5.88 ng/ml Standard Deviation 2.09

SECONDARY outcome

Timeframe: 24 hours after decannulation

Clinical and biochemical markers of organ failure

Outcome measures

Measure	7+ Days n=7 Participants on ECMO	<7 Days n=11 Participants on ECMO
Heart Injury as Determined by Serum Troponin Levels	9.54 ng/ml Standard Deviation 1.39	7.44 ng/ml Standard Deviation 1.41

SECONDARY outcome

Timeframe: 12 hours after ECMO commencement

Clinical and biochemical markers of organ failure

Outcome measures

Measure	7+ Days n=10 Participants on ECMO	<7 Days n=14 Participants on ECMO
Change of Serum Haemoglobin Levels	109.64 g/L Standard Deviation 20.81	112.07 g/L Standard Deviation 16.33

SECONDARY outcome

Timeframe: 24 hours after ECMO commencement

Clinical and biochemical markers of organ failure

Outcome measures

Measure	7+ Days n=10 Participants on ECMO	<7 Days n=14 Participants on ECMO
Change of Serum Haemoglobin Levels	114.30 g/L Standard Deviation 11.92	109.43 g/L Standard Deviation 24.52

SECONDARY outcome

Timeframe: 48 hours after ECMO commencement

Clinical and biochemical markers of organ failure

Outcome measures

Measure	7+ Days n=9 Participants on ECMO	<7 Days n=12 Participants on ECMO
Change of Serum Haemoglobin Levels	112.56 g/L Standard Deviation 9.14	113.08 g/L Standard Deviation 6.32

SECONDARY outcome

Timeframe: 72 hours after ECMO commencement

Clinical and biochemical markers of organ failure

Outcome measures

Measure	7+ Days n=10 Participants on ECMO	<7 Days n=9 Participants on ECMO
Change of Serum Haemoglobin Levels	112.90 g/L Standard Deviation 7.65	109.89 g/L Standard Deviation 3.79

SECONDARY outcome

Timeframe: 24 hours after decannulation

Clinical and biochemical markers of organ failure

Outcome measures

Measure	7+ Days n=8 Participants on ECMO	<7 Days n=13 Participants on ECMO
Change of Serum Haemoglobin Levels	109.25 g/L Standard Deviation 11.44	110.23 g/L Standard Deviation 12.15

Adverse Events

1 - Observational Case-Controls

Serious events: 3 serious events

Other events: 1 other events

Deaths: 3 deaths

Serious adverse events

Measure	1 - Observational Case-Controls n=24 participants at risk Observational Case-Controls.
Congenital, familial and genetic disorders Fatal	4.2% 1/24 • Until discharge from Hospital

Other adverse events

Measure	1 - Observational Case-Controls n=24 participants at risk Observational Case-Controls.
Congenital, familial and genetic disorders Resolved	4.2% 1/24 • Number of events 1 • Until discharge from Hospital

Additional Information

Clinical Trials Co-ordinator

University of Leicester

Phone: 0116 250 2427

Email: ha200@le.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place