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

• Status: Active, not recruiting
• Trial end date: 2021-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Utah
• Treatments: Calcium heparin; Dalteparin; Heparin; Heparin, Low-Molecular-Weight

Criteria

Inclusion Criteria:

• Patients undergoing surgical procedures

• Initiation of a heparin infusion at a rate of 500 units/hour intraoperatively or postoperatively

Exclusion Criteria:

• Age <18 years old

• Pregnant

• Incarcerated

• Mentally disabled