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

Sponsor

University of Utah (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03516656

Collaborator

(none)

Enrollment

Location

Arms

36.3

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Deep Vein Thrombosis Pulmonary Embolism Venous Thromboembolism	Drug: Standard heparin dose Drug: Real time heparin dose adjustment	Early Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Mar 23, 2018

Actual Primary Completion Date :

Jun 30, 2019

Anticipated Study Completion Date :

Mar 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard heparin dose 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 and transitioned to a weight-based dose by their surgeons. 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 Patients will be placed on heparin infusions per their surgeon's discretion.
Active Comparator: Real time heparin dose adjustment 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 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.

Arm

Intervention/Treatment

Active Comparator: Standard heparin dose

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 and transitioned to a weight-based dose by their surgeons. 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

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

Active Comparator: Real time heparin dose adjustment

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

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.

Outcome Measures

Primary Outcome Measures

Percentage of Anti-Xa Levels Within Target Range (0.1-0.35 IU/mL) [Through study completion, an average of 1 year]

Secondary Outcome Measures

Number of Rate Adjustments [Through study completion, an average of 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Utah	Salt Lake City	Utah	United States	84112

Sponsors and Collaborators

University of Utah

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Corinne Bertolaccini, Pharmacist, University of Utah

ClinicalTrials.gov Identifier:

NCT03516656

Other Study ID Numbers:

IRB_00107294

First Posted:

May 4, 2018

Last Update Posted:

Nov 13, 2020

Last Verified:

Nov 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Venous Thromboembolism

Venous Thrombosis

Heparin

Calcium heparin

Study Results

No Results Posted as of Nov 13, 2020