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Trial record 1 of 186 for:    Recruiting, Not yet recruiting, Available Studies | "Heparin"
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A Comparison of Dilute Versus Concentrated Heparin for CRRT Anticoagulation

This study is currently recruiting participants.
Verified May 2016 by Thomas Golper, Vanderbilt University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01318811
First Posted: March 18, 2011
Last Update Posted: May 9, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Thomas Golper, Vanderbilt University
  Purpose
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 Intervention Phase
Acute Kidney Injury Acute Renal Failure Heart Failure Drug: Dilute unfractionated heparin Drug: Standard concentration unfractionated heparin Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Thomas Golper, Vanderbilt University:

Primary Outcome Measures:
  • 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:
  • Bleeding complications [ Time Frame: 72 hours ]
    Information on minor bleeding complications, major bleeding complications, and need for blood product transfusions will be collected.


Estimated Enrollment: 200
Study Start Date: March 2011
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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)
  Contacts and Locations
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


Contacts
Contact: Thomas A Golper, MD (615) 343-2220 thomas.golper@vanderbilt.edu
Contact: Mohammed Sika, PhD (615) 936-2630 mohammed.sika@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Thomas A Golper, MD    615-343-2220    thomas.golper@vanderbilt.edu   
Contact: Mohammed Sika, PhD    (615) 936-2630    mohammed.sika@vanderbilt.edu   
Principal Investigator: Thomas A Golper, MD         
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Thomas A Golper, MD Vanderbilt University
  More Information

Publications:
Responsible Party: Thomas Golper, Professor of Medicine, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01318811     History of Changes
Other Study ID Numbers: VU 110162
First Submitted: March 17, 2011
First Posted: March 18, 2011
Last Update Posted: May 9, 2016
Last Verified: May 2016

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

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