Evaluation of Anti-Xa Levels in Surgery Patients Receiving Fixed Dose Heparin

Completed · Early Phase 1

Conditions studied: Deep-Venous Thrombosis, Pulmonary Embolism, Venous Thromboembolism

In brief

The purpose of this study is to determine if fixed dose heparin infusions at a rate of 500 units/hour are sufficient to maintain a target anti-Xa of 0.1-0.35 IU/mL for venous thromboembolism (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 500 units/hour.

Key facts

Study ID

NCT02970032

Run by

University of Utah

People needed

20

Starts

2016-11-10

Expected to finish

2017-12-08

Last updated by the study team

2019-07-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients undergoing surgical procedures
• Initiation of a heparin infusion at a rate of 500 units/hour intraoperatively or postoperatively

You may not qualify if…

• Age <18 years old
• Pregnant
• Incarcerated
• Mentally disabled

Where it is running

• Univeristy of Utah Hospital — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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