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Trial record 5 of 990 for:    Heparin sodium

A Comparison of Dilute Versus Concentrated Heparin for CRRT Anticoagulation

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ClinicalTrials.gov Identifier: NCT01318811
Recruitment Status : Terminated (lack of recruitment)
First Posted : March 18, 2011
Results First Posted : January 29, 2019
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
Thomas Golper, Vanderbilt University

Brief Summary:
Heparin is commonly used for anticoagulation of the extracorporeal circuit during continuous renal replacement therapy (CRRT) but the optimal mode of delivery has not yet been validated. Our study will compare dilute heparin to a standard concentration of heparin. The investigators hypothesize that heparin delivered in a dilute solution will augment coating of the filter fibers with anticoagulants, decreasing clotting events and increasing filter life. By improving delivery of heparin to the filter and circuit, where clotting events can disrupt dialysis, less heparin would be required for the extra-corporeal circuit and thus less heparin would be delivered back to the patient with blood return from the machine. By exposing the patient to less heparin it is hypothesized that fewer bleeding events would occur, making the dialysis treatment safer. If more of the filter's fibers remain patent and the filter is functional for a longer period of time, the CRRT would also be more effective.

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Acute Renal Failure Heart Failure Drug: Dilute unfractionated heparin Drug: Standard concentration unfractionated heparin Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparison of Dilute Unfractionated Heparin and Standard Concentrated Unfractionated Heparin Protocols for Anticoagulation of the Extra-corporeal Circuit During Continuous Renal Replacement Therapy in the ICU
Study Start Date : March 2011
Actual Primary Completion Date : April 3, 2016
Actual Study Completion Date : April 3, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Active Comparator: Dilute heparin
Arm A will receive dilute heparin delivered as an intravenous infusion proximal to the dialysis filter.
Drug: Dilute unfractionated heparin
Patients in the dilute heparin arm will receive a systemic loading dose of heparin of 15 units per kilogram of weight by rapid intravenous bolus. Then a maintenance rate of heparin of 7.5 U/Kg per hour will be started. Heparin will be delivered as a solution of 2 units/mL and the infusion will be prepared with 2,000 units of heparin in 1,000 mL of 0.9% NaCl and delivered intravenously proximal to the dialysis filter.
Other Name: Heparin

Active Comparator: Standard concentrated heparin
Arm B will receive standard concentrated heparin and will be delivered as an intravenous infusion proximal to the dialysis filter.
Drug: Standard concentration unfractionated heparin
Patients in the standard heparin arm will receive a systemic loading dose of heparin of 15 units per kilogram of weight by rapid intravenous bolus. Then a maintenance rate of heparin of 7.5 U/Kg per hour will be started and delivered in a standard concentration intravenously proximal to the dialysis filter via a syringe. The concentration of heparin used will be 1,000 units of heparin per 1 mL of 0.9% NaCl.
Other Name: Heparin




Primary Outcome Measures :
  1. Filter Life [ Time Frame: 72 hours ]
    The primary endpoint for this study will be the difference in filter life in hours between the group receiving dilute heparin and the group receiving standard concentrated heparin.


Secondary Outcome Measures :
  1. Number of Major Bleeding Complications [ Time Frame: 72 hours ]
    Information on major bleeding complications, and need for blood product transfusions will be collected.



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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:

  • Age greater than 18 years
  • Renal failure, electrolyte disturbance, or volume overload requiring continuous venovenous hemodialysis (CVVHD) as determined by the Nephrology consult service

Exclusion Criteria:

  • Age less than 18 years
  • Active bleeding
  • Coagulopathy as defined by baseline INR > 1.8, aPTT > 45 seconds, or platelet count < 50 thousand/μL
  • Active administration of systemic anticoagulation (such as warfarin, therapeutic unfractionated heparin, or therapeutic enoxaparin)
  • Contraindication to heparin (allergy, thrombocytopenia with platelet count < 50, known or suspected heparin induced thrombocytopenia [HIT])
  • Contraindication to systemic anticoagulation (recent surgical or other invasive procedure, significant bleeding disorder, concern for intracranial bleeding, or other contraindication as determined by treating physician)
  • Administration of drotrecogin (Xigris™)
  • Anticipated surgical or other invasive procedure that would necessitate withdrawal of anticoagulation within 72 hours
  • Expected termination of continuous renal replacement therapy (CRRT) or death in < 24 hours
  • The need for more than 500 cc an hour of IV fluids delivered proximal to the filter for the purpose of performing continuous venovenous hemofiltration (CVVH) or continuous venovenous hemodiafiltration (CVVHDF)

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): NCT01318811


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
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Principal Investigator: Thomas A Golper, MD Vanderbilt University

Publications:
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Responsible Party: Thomas Golper, Professor of Medicine, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01318811     History of Changes
Other Study ID Numbers: VU 110162
First Posted: March 18, 2011    Key Record Dates
Results First Posted: January 29, 2019
Last Update Posted: February 22, 2019
Last Verified: February 2019

Keywords provided by Thomas Golper, Vanderbilt University:
Heparin
CRRT
Continuous renal replacement therapy
CVVHD
Anticoagulation

Additional relevant MeSH terms:
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Heparin
Calcium heparin
Heart Failure
Acute Kidney Injury
Renal Insufficiency
Heart Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action