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

NCT03516656 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: IRB_00107294
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Deep Vein Thrombosis; Pulmonary Embolism; Venous Thromboembolism

Outcome Measures

Primary Outcomes (1)

• Percentage of Anti-Xa Levels Within Target Range (0.1-0.35 IU/mL)

  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 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

Real time heparin dose adjustment

ACTIVE COMPARATOR

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

Standard heparin dose DRUG

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

Standard heparin dose

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

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)

University of Utah

Salt Lake City, Utah, 84112, 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

Study Officials

• Anne Prazak, PharmD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: May 4, 2018
• Study Start: March 23, 2018
• Primary Completion: June 30, 2019
• Study Completion: August 24, 2021
• Last Updated: May 17, 2023

Record last verified: 2020-11

Locations

US (1)