Clinical trial

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

Name

IRB_00107294

Description

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.

Trial arms

Trial start

2018-03-23

Estimated PCD

2019-06-30

Trial end

2021-08-24

Status

Completed

Phase

Early phase I

Treatment

Standard heparin dose

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

Arms:

Standard heparin dose

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.

Arms:

Real time heparin dose adjustment

Size

Primary endpoint

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

Through study completion, an average of 1 year

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ACTUAL'}}

Updated at

2023-05-17

1 organization

Organization

University of Utah