Trial Outcomes & Findings for Ventricular Assist Device Anti-Factor Xa (VAD ANTIX) Monitoring Study: a Prospective Randomized Feasibility Trial (NCT NCT03143569)

NCT ID: NCT03143569

Last Updated: 2020-02-25

Results Overview

Questionnaires evaluating pragmatic application of nomograms. Question 1: The current heparin nomogram using (aPTT or anti-Xa depending on group) monitoring is easy to follow.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: 14 days of heparin therapy
• Results posted on: 2020-02-25

Participant Flow

Participant milestones

Measure	aPTT Nomogram aPTT guided heparin management aPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device. Anti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device	Anti-factor Xa Nomogram Anti-factor Xa guided heparin management aPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device. Anti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device
Overall Study STARTED	10	10
Overall Study COMPLETED	10	8
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ventricular Assist Device Anti-Factor Xa (VAD ANTIX) Monitoring Study: a Prospective Randomized Feasibility Trial

Baseline characteristics by cohort

Measure	aPTT Nomogram n=10 Participants aPTT guided heparin management aPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device. Anti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device	Anti-factor Xa Nomogram n=10 Participants Anti-factor Xa guided heparin management aPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device. Anti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Age, Continuous	53.3 years STANDARD_DEVIATION 12.3 • n=5 Participants	50.5 years STANDARD_DEVIATION 13.4 • n=7 Participants	51.9 years STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants
INTERMACS Profile score less than 4	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: 14 days of heparin therapy

Questionnaires evaluating pragmatic application of nomograms. Question 1: The current heparin nomogram using (aPTT or anti-Xa depending on group) monitoring is easy to follow.

Outcome measures

Measure	aPTT Nomogram n=136 Surveys aPTT guided heparin management aPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device.	Anti-factor Xa Nomogram n=112 Surveys Anti-factor Xa guided heparin management Anti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device
Nomogram Feasibility Surveys Completed	136 Surveys	112 Surveys
Nomogram Feasibility Affirmative Responses	136 Surveys	111 Surveys

PRIMARY outcome

Timeframe: 14 days of heparin therapy

Population: Collected Survey responses from bedside nurses. All surveys were collected as intended.

Questionnaires evaluating pragmatic application of nomograms. Question 2: Overall, I am satisfied with the utilization and implementation of the heparin monitoring nomogram.

Outcome measures

Measure	aPTT Nomogram n=136 Surveys aPTT guided heparin management aPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device.	Anti-factor Xa Nomogram n=112 Surveys Anti-factor Xa guided heparin management Anti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device
Nomogram Feasibility Surveys Completed	136 Surveys	112 Surveys
Nomogram Feasibility Affirmative Responses	136 Surveys	112 Surveys

PRIMARY outcome

Timeframe: 14 days of heparin therapy

Population: Collected Survey responses from bedside nurses. All surveys were collected as intended.

Questionnaires evaluating pragmatic application of nomograms. Question 3: Overall, I feel that this dosing nomogram is feasible.

Outcome measures

Measure	aPTT Nomogram n=136 Surveys aPTT guided heparin management aPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device.	Anti-factor Xa Nomogram n=112 Surveys Anti-factor Xa guided heparin management Anti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device
Nomogram Feasibility Surveys Completed	136 Surveys	112 Surveys
Nomogram Feasibility Affirmative Responses	135 Surveys	112 Surveys

PRIMARY outcome

Timeframe: 14 days of heparin therapy

Questionnaires evaluating pragmatic application of nomograms. Question 4: When my patient is on the heparin nomogram, I follow the dosing and monitoring instructions exactly.

Outcome measures

Measure	aPTT Nomogram n=136 Surveys aPTT guided heparin management aPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device.	Anti-factor Xa Nomogram n=112 Surveys Anti-factor Xa guided heparin management Anti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device
Nomogram Feasibility Surveys Completed	136 Surveys	112 Surveys
Nomogram Feasibility Affirmative Responses	136 Surveys	112 Surveys

PRIMARY outcome

Timeframe: 14 days of heparin therapy

Questionnaires evaluating pragmatic application of nomograms. Question 5: I often had to seek clarification from a coworker, pharmacist, NP, or MD regarding the nomogram instructions.

Outcome measures

Measure	aPTT Nomogram n=10 Participants aPTT guided heparin management aPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device.	Anti-factor Xa Nomogram n=112 Surveys Anti-factor Xa guided heparin management Anti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device
Nomogram Feasibility Surveys Completed	136 Surveys	112 Surveys
Nomogram Feasibility Affirmative Responses	45 Surveys	22 Surveys

PRIMARY outcome

Timeframe: 14 days of heparin therapy

Population: Each group received heparin anticoagulation and had heparin administration guided by a nomogram based on one of two different laboratory assays, aPTT or anti-Xa.

Amount of time sustained in therapeutic anticoagulation range

Outcome measures

Measure	aPTT Nomogram n=10 Participants aPTT guided heparin management aPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device.	Anti-factor Xa Nomogram n=10 Participants Anti-factor Xa guided heparin management Anti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device
Success of Nomogram	39.8 % of time patients test was therapeutic Interval 33.3 to 53.3	55.8 % of time patients test was therapeutic Interval 50.0 to 63.5

SECONDARY outcome

Timeframe: 14 days of heparin therapy

Population: paired aPTT samples compared with antiXa samples

Compare heparin dosing success between aPTT and anti-factor Xa nomograms. If aPTT was within therapeutic range of nomogram AND anti-factor Xa was within range in therapeutic nomogram, then paired values were deemed "concordent". Similiarly if both aPTT AND anti-factor Xa were above therapeutic range OR both below therapeutic range, then paired valued were deemed "concordent". Otherwise values deemd "discordant"

Outcome measures

Measure	aPTT Nomogram n=416 tests aPTT guided heparin management aPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device.	Anti-factor Xa Nomogram n=416 tests Anti-factor Xa guided heparin management Anti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device
Nomogram Concordance subtherapeutic	242 tests	166 tests
Nomogram Concordance therapeutic	138 tests	223 tests
Nomogram Concordance supratherapeutic	36 tests	27 tests

SECONDARY outcome

Timeframe: 14 days of heparin therapy

Number of dosing changes during heparin therapy until first therapeutic

Outcome measures

Measure	aPTT Nomogram n=10 Participants aPTT guided heparin management aPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device.	Anti-factor Xa Nomogram n=10 Participants Anti-factor Xa guided heparin management Anti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device
Dosing Changes	4.0 dosing changes Interval 1.0 to 7.0	3.0 dosing changes Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: 14 days of heparin therapy

Amount of time needed to achieve therapeutic dose from heparin initiation

Outcome measures

Measure	aPTT Nomogram n=10 Participants aPTT guided heparin management aPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device.	Anti-factor Xa Nomogram n=10 Participants Anti-factor Xa guided heparin management Anti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device
Time to Therapeutic Dose	48.0 hours Interval 12.0 to 60.0	33.0 hours Interval 6.0 to 48.0

Adverse Events

aPTT Nomogram

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Anti-factor Xa Nomogram

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	aPTT Nomogram n=10 participants at risk aPTT guided heparin management aPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device. Anti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device	Anti-factor Xa Nomogram n=10 participants at risk Anti-factor Xa guided heparin management aPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device. Anti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device
Blood and lymphatic system disorders Thrombosis	20.0% 2/10 • Number of events 2 • Collected during 14 day study duration.	30.0% 3/10 • Number of events 3 • Collected during 14 day study duration.
Blood and lymphatic system disorders Bleeding Complication	0.00% 0/10 • Collected during 14 day study duration.	0.00% 0/10 • Collected during 14 day study duration.

Other adverse events

Adverse event data not reported

Additional Information

Thomas J Graetz

WASHINGTON UNIVERSITY

Phone: 3147474155

Email: graetzt@wustl.edu

Results disclosure agreements

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