Trial Outcomes & Findings for The Effect of Prophylactic FFP Administration on ECMO Circuit Longevity (NCT NCT01903863)
NCT ID: NCT01903863
Last Updated: 2017-06-27
Results Overview
The primary endpoint is the ECMO pump longevity (measured in hours). The life of the circuit was defined as start of that circuit to circuit change or decannulation from ECMO for each patient. Circuit life was measured in hours
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
ECMO course (median 198 hours)
Results posted on
2017-06-27
Participant Flow
Participant milestones
| Measure |
Scheduled Fresh Frozen Plasma
Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours.
Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, or volume replacement.
|
Control
Patients in this arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.
Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
16
|
|
Overall Study
COMPLETED
|
13
|
16
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Scheduled Fresh Frozen Plasma
Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours.
Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, or volume replacement.
|
Control
Patients in this arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.
Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.
|
|---|---|---|
|
Overall Study
Physician Decision
|
2
|
0
|
Baseline Characteristics
The Effect of Prophylactic FFP Administration on ECMO Circuit Longevity
Baseline characteristics by cohort
| Measure |
Scheduled Fresh Frozen Plasma
n=15 Participants
Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours.
Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.
|
Control
n=16 Participants
Patients in this arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.
Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
0.33 years
n=5 Participants
|
0.063 years
n=7 Participants
|
0.096 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: ECMO course (median 198 hours)The primary endpoint is the ECMO pump longevity (measured in hours). The life of the circuit was defined as start of that circuit to circuit change or decannulation from ECMO for each patient. Circuit life was measured in hours
Outcome measures
| Measure |
Scheduled Fresh Frozen Plasma
n=15 Participants
Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours.
Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, or volume replacement.
|
Control
n=16 Participants
Patients in this arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.
Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.
|
|---|---|---|
|
ECMO Pump Longevity
|
187 hours
Interval 94.0 to 329.0
|
131 hours
Interval 73.0 to 251.0
|
SECONDARY outcome
Timeframe: ECMO course (median 198 hours)Complications associated with coagulation in both the patient and the pump will be collected.
Outcome measures
| Measure |
Scheduled Fresh Frozen Plasma
n=15 Participants
Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours.
Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, or volume replacement.
|
Control
n=16 Participants
Patients in this arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.
Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.
|
|---|---|---|
|
Hemorrhagic and Thrombotic Complications
Intracranial hemorrhage
|
5 participants
|
1 participants
|
|
Hemorrhagic and Thrombotic Complications
Surgical site bleed
|
2 participants
|
2 participants
|
|
Hemorrhagic and Thrombotic Complications
Gastrointestinal hemrrohage
|
2 participants
|
1 participants
|
|
Hemorrhagic and Thrombotic Complications
Stroke
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: ECMO course (median 198 hours)Compared antithrombin levels in neonates in control versus treatment group
Outcome measures
| Measure |
Scheduled Fresh Frozen Plasma
n=15 Participants
Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours.
Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, or volume replacement.
|
Control
n=16 Participants
Patients in this arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.
Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.
|
|---|---|---|
|
Antithrombin Levels
|
71 percentage of antithrombin
Interval 35.0 to 81.0
|
63 percentage of antithrombin
Interval 35.0 to 77.0
|
SECONDARY outcome
Timeframe: ECMO course (median 198 hours)Compare plasma free hemoglobin levels between control and treatment group
Outcome measures
| Measure |
Scheduled Fresh Frozen Plasma
n=15 Participants
Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours.
Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, or volume replacement.
|
Control
n=16 Participants
Patients in this arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.
Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.
|
|---|---|---|
|
Plasma Free Hemoglobin
|
47 mg/dL
Interval 30.0 to 130.0
|
56 mg/dL
Interval 25.0 to 127.0
|
SECONDARY outcome
Timeframe: ECMO course (median 198 hours)Compared red blood cell transfusion during ECMO for control versus treatment group
Outcome measures
| Measure |
Scheduled Fresh Frozen Plasma
n=15 Participants
Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours.
Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, or volume replacement.
|
Control
n=16 Participants
Patients in this arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.
Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.
|
|---|---|---|
|
Red Blood Cell Transfusion
|
7.2 ml/kilogram/ECMO day
Interval 3.3 to 16.3
|
4.7 ml/kilogram/ECMO day
Interval 1.2 to 11.0
|
SECONDARY outcome
Timeframe: ECMO course (median 198 hours)Compared time in hours to goal aPTT for control versus treatment group
Outcome measures
| Measure |
Scheduled Fresh Frozen Plasma
n=15 Participants
Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours.
Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, or volume replacement.
|
Control
n=16 Participants
Patients in this arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.
Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.
|
|---|---|---|
|
Time to Therapeutic aPTT
|
658 hours
Interval 213.0 to 1870.0
|
676 hours
Interval 358.0 to 1890.0
|
SECONDARY outcome
Timeframe: ECMO course (median 198 hours)Compared platelet transfusion during ECMO for control versus treatment group
Outcome measures
| Measure |
Scheduled Fresh Frozen Plasma
n=15 Participants
Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours.
Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, or volume replacement.
|
Control
n=16 Participants
Patients in this arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.
Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.
|
|---|---|---|
|
Platelets Transfusion Requirement
|
12.5 ml/kilogram/ECMO day
Interval 1.2 to 22.7
|
24.8 ml/kilogram/ECMO day
Interval 12.1 to 30.8
|
SECONDARY outcome
Timeframe: ECMO course (median 198 hours)Compared fresh frozen plasma transfusion during ECMO for control versus treatment group
Outcome measures
| Measure |
Scheduled Fresh Frozen Plasma
n=15 Participants
Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours.
Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, or volume replacement.
|
Control
n=16 Participants
Patients in this arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.
Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.
|
|---|---|---|
|
Fresh Frozen Plasma Transfusion Requirements
|
10.1 ml/kilogram/ECMO day
Interval 1.8 to 13.9
|
8.8 ml/kilogram/ECMO day
Interval 2.5 to 17.7
|
Adverse Events
Scheduled Fresh Frozen Plasma
Serious events: 5 serious events
Other events: 0 other events
Deaths: 6 deaths
Control
Serious events: 1 serious events
Other events: 0 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Scheduled Fresh Frozen Plasma
n=15 participants at risk
Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours.
Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, or volume replacement.
|
Control
n=16 participants at risk
Patients in this arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.
Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.
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|---|---|---|
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Nervous system disorders
Intracranial hemorrhage
|
33.3%
5/15 • Number of events 5
|
6.2%
1/16 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Caroline Ozment
Duke University Hospital
Phone: 919-681-2554
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place