Trial Outcomes & Findings for Does Plasma Reduce Bleeding in Patients Undergoing Invasive Procedures (NCT NCT02637427)
NCT ID: NCT02637427
Last Updated: 2021-08-18
Results Overview
Change from pre-procedure hemoglobin to lowest within 2 days after procedure
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
57 participants
Primary outcome timeframe
within 2 days post procedure
Results posted on
2021-08-18
Participant Flow
Participant milestones
| Measure |
Fresh Frozen Plasma Transfusion
Pre-procedure fresh frozen plasma transfusion (15 cc per Kg, range 10-20 cc/Kg, to a maximum of 5 units)
Fresh frozen plasma transfusion: Pre-procedure fresh frozen plasma transfusion (15 cc per Kg to a maximum of 5 units)
|
No Transfusion
No transfusions prior to the procedure
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
30
|
|
Overall Study
COMPLETED
|
27
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Does Plasma Reduce Bleeding in Patients Undergoing Invasive Procedures
Baseline characteristics by cohort
| Measure |
Fresh Frozen Plasma Transfusion
n=27 Participants
Pre-procedure fresh frozen plasma transfusion (15 cc per Kg, range 10-20 cc/Kg, to a maximum of 5 units)
Fresh frozen plasma transfusion: Pre-procedure fresh frozen plasma transfusion (15 cc per Kg to a maximum of 5 units)
|
No Transfusion
n=30 Participants
No transfusions prior to the procedure
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.5 years
STANDARD_DEVIATION 18.0 • n=5 Participants
|
58.2 years
STANDARD_DEVIATION 13.9 • n=7 Participants
|
56.0 years
STANDARD_DEVIATION 16.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
30 participants
n=7 Participants
|
57 participants
n=5 Participants
|
|
Liver disease
|
15 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Hypertension
|
14 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Diabetes
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Coronary artery disease
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Congestive heart failure
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Chronic Obstructive Pulmonary Disease (COPD)
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Thromboembolism
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Prior history of bleeding
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Metastatic carcinoma
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: within 2 days post procedureChange from pre-procedure hemoglobin to lowest within 2 days after procedure
Outcome measures
| Measure |
Fresh Frozen Plasma Transfusion
n=27 Participants
Pre-procedure fresh frozen plasma transfusion (15 cc per Kg, range 10-20 cc/Kg, to a maximum of 5 units)
Fresh frozen plasma transfusion: Pre-procedure fresh frozen plasma transfusion (15 cc per Kg to a maximum of 5 units)
|
No Transfusion
n=30 Participants
No transfusions prior to the procedure
|
|---|---|---|
|
Change in Hemoglobin Level
|
-0.6 g/dL
Standard Deviation 1.0
|
-0.4 g/dL
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: within 2 days post procedureDifferences in number of units of red blood cell transfusions between the two study arms
Outcome measures
| Measure |
Fresh Frozen Plasma Transfusion
n=27 Participants
Pre-procedure fresh frozen plasma transfusion (15 cc per Kg, range 10-20 cc/Kg, to a maximum of 5 units)
Fresh frozen plasma transfusion: Pre-procedure fresh frozen plasma transfusion (15 cc per Kg to a maximum of 5 units)
|
No Transfusion
n=30 Participants
No transfusions prior to the procedure
|
|---|---|---|
|
Number of Red Blood Cell Transfusions
|
0 units
Interval 0.0 to 0.0
|
0 units
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: within 2 days post procedureDifference in rates between the two study arms
Outcome measures
| Measure |
Fresh Frozen Plasma Transfusion
n=27 Participants
Pre-procedure fresh frozen plasma transfusion (15 cc per Kg, range 10-20 cc/Kg, to a maximum of 5 units)
Fresh frozen plasma transfusion: Pre-procedure fresh frozen plasma transfusion (15 cc per Kg to a maximum of 5 units)
|
No Transfusion
n=30 Participants
No transfusions prior to the procedure
|
|---|---|---|
|
Number of Participants With Transfusion Associated Cardiac Overload (TACO)
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: with 2 days post procedureDifference in rates between the two study arms
Outcome measures
| Measure |
Fresh Frozen Plasma Transfusion
n=27 Participants
Pre-procedure fresh frozen plasma transfusion (15 cc per Kg, range 10-20 cc/Kg, to a maximum of 5 units)
Fresh frozen plasma transfusion: Pre-procedure fresh frozen plasma transfusion (15 cc per Kg to a maximum of 5 units)
|
No Transfusion
n=30 Participants
No transfusions prior to the procedure
|
|---|---|---|
|
Number of Participants With Transfusion Related Acute Lung Injury (TRALI).
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: with 2 days post procedure2g/dL or greater fall in hemoglobin level
Outcome measures
| Measure |
Fresh Frozen Plasma Transfusion
n=27 Participants
Pre-procedure fresh frozen plasma transfusion (15 cc per Kg, range 10-20 cc/Kg, to a maximum of 5 units)
Fresh frozen plasma transfusion: Pre-procedure fresh frozen plasma transfusion (15 cc per Kg to a maximum of 5 units)
|
No Transfusion
n=30 Participants
No transfusions prior to the procedure
|
|---|---|---|
|
Number of Participants With Major Bleed
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: day of procedureChange from pre-procedure INR level
Outcome measures
| Measure |
Fresh Frozen Plasma Transfusion
n=19 Participants
Pre-procedure fresh frozen plasma transfusion (15 cc per Kg, range 10-20 cc/Kg, to a maximum of 5 units)
Fresh frozen plasma transfusion: Pre-procedure fresh frozen plasma transfusion (15 cc per Kg to a maximum of 5 units)
|
No Transfusion
n=20 Participants
No transfusions prior to the procedure
|
|---|---|---|
|
Change in International Normalized Ratio (INR) Level Post Procedure
|
-0.24 ratio
Standard Deviation 0.26
|
0 ratio
Standard Deviation 0.15
|
SECONDARY outcome
Timeframe: day 1 post procedureChange from pre-procedure INR level
Outcome measures
| Measure |
Fresh Frozen Plasma Transfusion
n=25 Participants
Pre-procedure fresh frozen plasma transfusion (15 cc per Kg, range 10-20 cc/Kg, to a maximum of 5 units)
Fresh frozen plasma transfusion: Pre-procedure fresh frozen plasma transfusion (15 cc per Kg to a maximum of 5 units)
|
No Transfusion
n=27 Participants
No transfusions prior to the procedure
|
|---|---|---|
|
Change in INR Level Day 1
|
-0.22 ratio
Standard Deviation 0.19
|
-0.03 ratio
Standard Deviation 0.19
|
SECONDARY outcome
Timeframe: day 2 post procedureChange from pre-procedure INR level
Outcome measures
| Measure |
Fresh Frozen Plasma Transfusion
n=22 Participants
Pre-procedure fresh frozen plasma transfusion (15 cc per Kg, range 10-20 cc/Kg, to a maximum of 5 units)
Fresh frozen plasma transfusion: Pre-procedure fresh frozen plasma transfusion (15 cc per Kg to a maximum of 5 units)
|
No Transfusion
n=20 Participants
No transfusions prior to the procedure
|
|---|---|---|
|
Change in INR Level Day 2
|
-0.09 ratio
Standard Deviation 0.39
|
0 ratio
Standard Deviation 0.19
|
SECONDARY outcome
Timeframe: in-hospital up to 7 daysDeath
Outcome measures
| Measure |
Fresh Frozen Plasma Transfusion
n=27 Participants
Pre-procedure fresh frozen plasma transfusion (15 cc per Kg, range 10-20 cc/Kg, to a maximum of 5 units)
Fresh frozen plasma transfusion: Pre-procedure fresh frozen plasma transfusion (15 cc per Kg to a maximum of 5 units)
|
No Transfusion
n=30 Participants
No transfusions prior to the procedure
|
|---|---|---|
|
Mortality (Number of Participants)
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: within 2 days post procedurePneumonia or blood stream infection
Outcome measures
| Measure |
Fresh Frozen Plasma Transfusion
n=27 Participants
Pre-procedure fresh frozen plasma transfusion (15 cc per Kg, range 10-20 cc/Kg, to a maximum of 5 units)
Fresh frozen plasma transfusion: Pre-procedure fresh frozen plasma transfusion (15 cc per Kg to a maximum of 5 units)
|
No Transfusion
n=30 Participants
No transfusions prior to the procedure
|
|---|---|---|
|
Number of Participants With Infection
Pneumonia
|
0 Participants
|
1 Participants
|
|
Number of Participants With Infection
Blood stream infection
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: within 2 days post procedurenew admission to the intensive care unit
Outcome measures
| Measure |
Fresh Frozen Plasma Transfusion
n=27 Participants
Pre-procedure fresh frozen plasma transfusion (15 cc per Kg, range 10-20 cc/Kg, to a maximum of 5 units)
Fresh frozen plasma transfusion: Pre-procedure fresh frozen plasma transfusion (15 cc per Kg to a maximum of 5 units)
|
No Transfusion
n=30 Participants
No transfusions prior to the procedure
|
|---|---|---|
|
Number of Participants With ICU Admission
|
1 Participants
|
2 Participants
|
Adverse Events
Fresh Frozen Plasma Transfusion
Serious events: 2 serious events
Other events: 0 other events
Deaths: 1 deaths
No Transfusion
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fresh Frozen Plasma Transfusion
n=27 participants at risk
Pre-procedure fresh frozen plasma transfusion (15 cc per Kg, range 10-20 cc/Kg, to a maximum of 5 units)
Fresh frozen plasma transfusion: Pre-procedure fresh frozen plasma transfusion (15 cc per Kg to a maximum of 5 units)
|
No Transfusion
n=30 participants at risk
No transfusions prior to the procedure
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/27 • In-hospital (for up to 7 days)
Adverse events were captured via daily medical record review
|
3.3%
1/30 • Number of events 1 • In-hospital (for up to 7 days)
Adverse events were captured via daily medical record review
|
|
Cardiac disorders
Congestive Heart Failure
|
0.00%
0/27 • In-hospital (for up to 7 days)
Adverse events were captured via daily medical record review
|
6.7%
2/30 • Number of events 2 • In-hospital (for up to 7 days)
Adverse events were captured via daily medical record review
|
|
Infections and infestations
Blood Stream Infrection
|
7.4%
2/27 • Number of events 2 • In-hospital (for up to 7 days)
Adverse events were captured via daily medical record review
|
3.3%
1/30 • Number of events 1 • In-hospital (for up to 7 days)
Adverse events were captured via daily medical record review
|
|
Infections and infestations
Septic Shock
|
0.00%
0/27 • In-hospital (for up to 7 days)
Adverse events were captured via daily medical record review
|
3.3%
1/30 • Number of events 1 • In-hospital (for up to 7 days)
Adverse events were captured via daily medical record review
|
|
Hepatobiliary disorders
Liver Failure
|
3.7%
1/27 • Number of events 1 • In-hospital (for up to 7 days)
Adverse events were captured via daily medical record review
|
0.00%
0/30 • In-hospital (for up to 7 days)
Adverse events were captured via daily medical record review
|
Other adverse events
Adverse event data not reported
Additional Information
Jeffrey L Carson, MD
Rutgers, The State University of New Jersey
Phone: 732-235-7122
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place