NCT03516656

Evaluation of Anti-Xa Levels in Surgery Patients Receiving Weight-based Heparin

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if weight-based heparin infusions at a rate of 10 units/kg/hour are sufficient to maintain a target anti-Xa of 0.1-0.35 IU/mL for VTE prophylaxis in patients undergoing microvascular surgery. Additionally, a pilot protocol has been developed to titrate these heparin infusions to ensure patients have sufficient VTE prophylaxis. All patients will be enrolled in the observational arm of the study and receive anti-Xa level monitoring. Patients with out-of-range anti-Xa levels will cross over to the interventional arm of the study and receive real time heparin infusion dose adjustments per the pilot protocol. The primary outcome measured will be the percentage of patients with anti-Xa levels in the target range of 0.1-0.35 IU/mL while on a heparin infusion at 10 units/kg/hour.

Conditions

• Deep Vein Thrombosis
• Pulmonary Embolism
• Venous Thromboembolism

Interventions

Type	Name	Description
DRUG	Standard heparin dose	Patients will be placed on heparin infusions per their surgeon's discretion.
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.

Timeline

• Start date: 2018-03-23
• Primary completion: 2019-06-30
• Completion: 2021-08-24
• First posted: 2018-05-04
• Last updated: 2023-05-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study