Evaluation of Anti-Xa Levels in Surgery Patients Receiving Weight-based Heparin
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|ClinicalTrials.gov Identifier: NCT03516656|
Recruitment Status : Active, not recruiting
First Posted : May 4, 2018
Last Update Posted : June 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Deep Vein Thrombosis Pulmonary Embolism Venous Thromboembolism||Drug: Standard heparin dose Drug: Real time heparin dose adjustment||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Anti-Xa Levels in Surgery Patients Receiving Weight-based Heparin|
|Actual Study Start Date :||March 23, 2018|
|Estimated Primary Completion Date :||July 1, 2019|
|Estimated Study Completion Date :||October 1, 2019|
Active Comparator: Standard heparin dose
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 and transitioned to a weight-based dose by their surgeons. 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.
Drug: Standard heparin dose
Patients will be placed on heparin infusions per their surgeon's discretion.
Active Comparator: Real time heparin dose adjustment
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
Drug: 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.
- Percentage of Anti-Xa Levels Within Target Range (0.1-0.35 IU/mL) [ Time Frame: Through study completion, an average of 1 year ]
- Number of Rate Adjustments [ Time Frame: Through study completion, an average of 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03516656
|United States, Utah|
|University of Utah|
|Salt Lake City, Utah, United States, 84112|