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Completed

NCT Number: NCT02970032

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

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.

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Key information

Conditions

Deep-Venous Thrombosis Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Pulmonary Embolism Respiratory Tract Diseases Thromboembolism Thrombosis Vascular Diseases Venous Thromboembolism Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Univeristy of Utah Hospital

Salt Lake City, Utah, 84132, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Standard heparin dose

Drug

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

Primary outcomes

  1. Number of Participants With Anti-Xa Levels Within Target Range (0.1-0.35 IU/mL)

    Time frame: Through study completion, an average of 1 year.

    Anti-Xa levels are used to monitor anticoagulant therapy.

Secondary outcomes

  1. Number of Rate Adjustments

    Time frame: Through study completion, an average of 1 year.

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

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 21, 2016
Registry last updated
Jul 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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