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Trial record 10 of 56 for:    "Lung Disease" | "Dalteparin"

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

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ClinicalTrials.gov Identifier: NCT03516656
Recruitment Status : Active, not recruiting
First Posted : May 4, 2018
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
Corinne Bertolaccini, University of Utah

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

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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 Weight-based Heparin
Actual Study Start Date : March 23, 2018
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine


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.




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 ]

Secondary Outcome Measures :
  1. Number of Rate Adjustments [ 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): NCT03516656


Locations
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United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah

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Responsible Party: Corinne Bertolaccini, Pharmacist, University of Utah
ClinicalTrials.gov Identifier: NCT03516656     History of Changes
Other Study ID Numbers: IRB_00107294
First Posted: May 4, 2018    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Lung Diseases
Dalteparin
Pulmonary Embolism
Thrombosis
Thromboembolism
Embolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Heparin
Calcium heparin
Heparin, Low-Molecular-Weight
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action