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

Pulmonary Embolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02970032
• Other study ID #: IRB_00095514
• Status: Completed
• Phase: Early Phase 1
• Start date: November 10, 2016
• Est. completion date: December 8, 2017

Study information

• Verified date: July 2019
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 8, 2017
• Est. primary completion date: September 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deep-Venous Thrombosis
• Embolism
• Pulmonary Embolism
• Thromboembolism
• Thrombosis
• Venous Thromboembolism
• Venous Thrombosis

Intervention

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.
• Standard heparin dose
Patients will be placed on heparin infusions per their surgeon's discretion.

Locations

Country	Name	City	State
United States	Univeristy of Utah Hospital	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Anti-Xa Levels Within Target Range (0.1-0.35 IU/mL)	Anti-Xa levels are used to monitor anticoagulant therapy.	Through study completion, an average of 1 year.
Secondary	Number of Rate Adjustments	Heparin rate adjustments were made for out of range anti-Xa levels (<0.1 and >0.35)	Through study completion, an average of 1 year.