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

NCT02970032 | Completed Early Phase 1 Results DMC

• 1 other identifier: IRB_00095514
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Deep-Venous Thrombosis; Pulmonary Embolism; Venous Thromboembolism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Rate Adjustments

  Through study completion, an average of 1 year.

Study Arms (2)

Standard heparin dose

ACTIVE COMPARATOR

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. 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

Real time heparin dose adjustment

EXPERIMENTAL

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

Interventions

Real time heparin dose adjustment DRUG

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.

Real time heparin dose adjustment

Standard heparin dose DRUG

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

Standard heparin dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Univeristy of Utah Hospital

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Venous Thrombosis; Pulmonary Embolism; Venous Thromboembolism

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism; Thromboembolism

Results Point of Contact

• Title: Corinne Bertolaccini, PharmD
• Organization: University of Utah Health

Corinne.Bertolaccini@hsc.utah.edu

801-581-2167

Study Officials

• Corinne Bertolaccini, PharmD

  University of Utah Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharmacist

Study Record Dates

• First Submitted: November 11, 2016
• First Posted: November 21, 2016
• Study Start: November 10, 2016
• Primary Completion: September 10, 2017
• Study Completion: December 8, 2017
• Last Updated: July 24, 2019
• Results First Posted: June 24, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)