Trial Outcomes & Findings for Evaluation of Anti-Xa Levels in Surgery Patients Receiving Fixed Dose Heparin (NCT NCT02970032)
NCT ID: NCT02970032
Last Updated: 2019-07-24
Results Overview
Anti-Xa levels are used to monitor anticoagulant therapy.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
20 participants
Primary outcome timeframe
Through study completion, an average of 1 year.
Results posted on
2019-07-24
Participant Flow
All 20 patients that were enrolled in the standard heparin dose arm crossed over into the real time heparin dose adjustment arm per the pilot protocol with undetectable anti-Xa levels (\<0.10).
Participant milestones
| Measure |
Standard Heparin Dose Followed by Dose Adjustment
The investigators will identify surgical patients placed on fixed dose heparin infusions at their attending surgeon's discretion-the proposed research will not dictate the initiation of the heparin drip intraoperatively. However, the investigators will identify patients already on heparin, evaluate steady state heparin anti-Xa levels and adjust patient's dose if necessary based on steady state anti-Xa levels. Eligible patients will be started on heparin fixed-dose intraoperatively. Steady state anti-Xa levels will be drawn at least 6 hours after initiation of heparin infusion. Goal anti-Xa levels will be 0.1-0.35 IU/mL.
Patients with identified out of range levels will receive pharmacist-driven real time heparin dose adjustment and will receive follow-up steady state anti-Xa levels. Anti-Xa level monitoring will be discontinued when in range peak levels are obtained, when heparin infusions are discontinued at surgeon discretion, or when the patient is discharged.
|
|---|---|
|
Standard Heparin Dose
STARTED
|
20
|
|
Standard Heparin Dose
COMPLETED
|
20
|
|
Standard Heparin Dose
NOT COMPLETED
|
0
|
|
Real Time Heparin Dose Adjustment
STARTED
|
20
|
|
Real Time Heparin Dose Adjustment
COMPLETED
|
20
|
|
Real Time Heparin Dose Adjustment
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Standard Heparin Dose Followed by Dose Adjustment
n=20 Participants
The investigators will identify surgical patients placed on fixed dose heparin infusions at their attending surgeon's discretion-the proposed research will not dictate the initiation of the heparin drip intraoperatively. However, the investigators will identify patients already on heparin, evaluate steady state heparin anti-Xa levels and adjust patient's dose if necessary based on steady state anti-Xa levels.Steady state anti-Xa levels will be drawn at least 6 hours after initiation of heparin infusion. Goal anti-Xa levels will be 0.1-0.35 IU/mL. Patients with identified out of range levels will receive pharmacist-driven real time heparin dose adjustment and will receive follow-up steady state anti-Xa levels. Anti-Xa level monitoring will be discontinued when in range peak levels are obtained, when heparin infusions are discontinued at surgeon discretion, or when the patient is discharged.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=20 Participants
|
|
Weight
|
20 Kilograms
n=20 Participants
|
PRIMARY outcome
Timeframe: Through study completion, an average of 1 year.Anti-Xa levels are used to monitor anticoagulant therapy.
Outcome measures
| Measure |
Standard Heparin Dose Followed by Dose Adjustment
n=20 Participants
The investigators will identify surgical patients placed on fixed dose heparin infusions at their attending surgeon's discretion-the proposed research will not dictate the initiation of the heparin drip intraoperatively. However, the investigators will identify patients already on heparin, evaluate steady state heparin anti-Xa levels and adjust patient's dose if necessary based on steady state anti-Xa levels. Eligible patients will be started on heparin fixed-dose intraoperatively. Steady state anti-Xa levels will be drawn at least 6 hours after initiation of heparin infusion. Goal anti-Xa levels will be 0.1-0.35 IU/mL.
Patients with identified out of range levels will receive pharmacist-driven real time heparin dose adjustment and will receive follow-up steady state anti-Xa levels. Anti-Xa level monitoring will be discontinued when in range peak levels are obtained, when heparin infusions are discontinued at surgeon discretion, or when the patient is discharged.
|
|---|---|
|
Number of Participants With Anti-Xa Levels Within Target Range (0.1-0.35 IU/mL)
Standard Heparin Dose
|
0 Participants
|
|
Number of Participants With Anti-Xa Levels Within Target Range (0.1-0.35 IU/mL)
Dose adjustment
|
12 Participants
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 year.Population: During the dose adjustment period, anti-Xa levels were monitored and dose adjustments made per the pilot protocol.
Heparin rate adjustments were made for out of range anti-Xa levels (\<0.1 and \>0.35)
Outcome measures
| Measure |
Standard Heparin Dose Followed by Dose Adjustment
n=20 Participants
The investigators will identify surgical patients placed on fixed dose heparin infusions at their attending surgeon's discretion-the proposed research will not dictate the initiation of the heparin drip intraoperatively. However, the investigators will identify patients already on heparin, evaluate steady state heparin anti-Xa levels and adjust patient's dose if necessary based on steady state anti-Xa levels. Eligible patients will be started on heparin fixed-dose intraoperatively. Steady state anti-Xa levels will be drawn at least 6 hours after initiation of heparin infusion. Goal anti-Xa levels will be 0.1-0.35 IU/mL.
Patients with identified out of range levels will receive pharmacist-driven real time heparin dose adjustment and will receive follow-up steady state anti-Xa levels. Anti-Xa level monitoring will be discontinued when in range peak levels are obtained, when heparin infusions are discontinued at surgeon discretion, or when the patient is discharged.
|
|---|---|
|
Number of Rate Adjustments
|
4.5 Rate adjustments
Interval 1.0 to 9.0
|
Adverse Events
Standard Heparin Dose
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Real Time Heparin Dose Adjustment
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Heparin Dose
n=20 participants at risk
The investigators will identify surgical patients placed on fixed dose heparin infusions at their attending surgeon's discretion-the proposed research will not dictate the initiation of the heparin drip intraoperatively. However, the investigators will identify patients already on heparin, evaluate steady state heparin anti-Xa levels and adjust patient's dose if necessary based on steady state anti-Xa levels. Eligible patients will be started on heparin fixed-dose intraoperatively. Steady state anti-Xa levels will be drawn at least 6 hours after initiation of heparin infusion. Goal anti-Xa levels will be 0.1-0.35 IU/mL.
Standard heparin dose: Patients will be placed on heparin infusions per their surgeon's discretion.
|
Real Time Heparin Dose Adjustment
n=20 participants at risk
Patients with identified out of range levels will receive pharmacist-driven real time heparin dose adjustment and will receive follow-up steady state anti-Xa levels. Anti-Xa level monitoring will be discontinued when in range peak levels are obtained, when heparin infusions are discontinued at surgeon discretion, or when the patient is discharged.
Real time heparin dose adjustment: Patients will have steady state anti-Xa levels drawn at least 6 hours after initiation of heparin infusion. Patients with out of range anti-Xa levels will receive real time heparin dose adjustment followed by repeat anti-Xa levels.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
5.0%
1/20 • Number of events 1 • 3 months from discharge
|
5.0%
1/20 • Number of events 1 • 3 months from discharge
|
Other adverse events
| Measure |
Standard Heparin Dose
n=20 participants at risk
The investigators will identify surgical patients placed on fixed dose heparin infusions at their attending surgeon's discretion-the proposed research will not dictate the initiation of the heparin drip intraoperatively. However, the investigators will identify patients already on heparin, evaluate steady state heparin anti-Xa levels and adjust patient's dose if necessary based on steady state anti-Xa levels. Eligible patients will be started on heparin fixed-dose intraoperatively. Steady state anti-Xa levels will be drawn at least 6 hours after initiation of heparin infusion. Goal anti-Xa levels will be 0.1-0.35 IU/mL.
Standard heparin dose: Patients will be placed on heparin infusions per their surgeon's discretion.
|
Real Time Heparin Dose Adjustment
n=20 participants at risk
Patients with identified out of range levels will receive pharmacist-driven real time heparin dose adjustment and will receive follow-up steady state anti-Xa levels. Anti-Xa level monitoring will be discontinued when in range peak levels are obtained, when heparin infusions are discontinued at surgeon discretion, or when the patient is discharged.
Real time heparin dose adjustment: Patients will have steady state anti-Xa levels drawn at least 6 hours after initiation of heparin infusion. Patients with out of range anti-Xa levels will receive real time heparin dose adjustment followed by repeat anti-Xa levels.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
5.0%
1/20 • Number of events 1 • 3 months from discharge
|
5.0%
1/20 • Number of events 1 • 3 months from discharge
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place