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

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ClinicalTrials.gov Identifier: NCT02970032
Recruitment Status : Active, not recruiting
First Posted : November 21, 2016
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
Corinne Bertolaccini, University of Utah

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 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.

Condition or disease Intervention/treatment Phase
Deep-Venous Thrombosis Pulmonary Embolism Venous Thromboembolism Drug: Real time heparin dose adjustment Drug: Standard heparin dose Early Phase 1

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Study Type : Interventional  (Clinical Trial)
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 Fixed Dose Heparin
Actual Study Start Date : November 10, 2016
Actual Primary Completion Date : September 10, 2017
Estimated Study Completion Date : December 8, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

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. 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.

Experimental: 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.




Primary Outcome Measures :
  1. Percentage of anti-Xa levels within target range (0.1-0.35 IU/mL) [ Time Frame: Through study completion, an average of 1 year. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02970032


Locations
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United States, Utah
Univeristy of Utah Hospital
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah

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Responsible Party: Corinne Bertolaccini, Pharmacist, University of Utah
ClinicalTrials.gov Identifier: NCT02970032     History of Changes
Other Study ID Numbers: IRB_00095514
First Posted: November 21, 2016    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
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Heparin
Calcium heparin
Heparin, Low-Molecular-Weight
Thrombosis
Thromboembolism
Embolism
Venous Thromboembolism
Pulmonary Embolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Dalteparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action