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

Primary Purpose

Deep-Venous Thrombosis, Pulmonary Embolism, Venous Thromboembolism

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Real time heparin dose adjustment
Standard heparin dose
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Deep-Venous Thrombosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Univeristy of Utah Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard heparin dose

Real time heparin dose adjustment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Rate Adjustments
Heparin rate adjustments were made for out of range anti-Xa levels (<0.1 and >0.35)

Full Information

First Posted
November 11, 2016
Last Updated
July 9, 2019
Sponsor
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT02970032
Brief Title
Evaluation of Anti-Xa Levels in Surgery Patients Receiving Fixed Dose Heparin
Official Title
Evaluation of Anti-Xa Levels in Surgery Patients Receiving Fixed Dose Heparin
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
November 10, 2016 (Actual)
Primary Completion Date
September 10, 2017 (Actual)
Study Completion Date
December 8, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep-Venous Thrombosis, Pulmonary Embolism, Venous Thromboembolism

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard heparin dose
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Real time heparin dose adjustment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Real time heparin dose adjustment
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Standard heparin dose
Intervention Description
Patients will be placed on heparin infusions per their surgeon's discretion.
Primary Outcome Measure Information:
Title
Number of Participants With Anti-Xa Levels Within Target Range (0.1-0.35 IU/mL)
Description
Anti-Xa levels are used to monitor anticoagulant therapy.
Time Frame
Through study completion, an average of 1 year.
Secondary Outcome Measure Information:
Title
Number of Rate Adjustments
Description
Heparin rate adjustments were made for out of range anti-Xa levels (<0.1 and >0.35)
Time Frame
Through study completion, an average of 1 year.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corinne Bertolaccini, PharmD
Organizational Affiliation
University of Utah Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univeristy of Utah Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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