A Comparison of Dilute Versus Concentrated Heparin for CRRT Anticoagulation
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|ClinicalTrials.gov Identifier: NCT01318811|
Recruitment Status : Recruiting
First Posted : March 18, 2011
Last Update Posted : May 9, 2016
|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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||September 2020|
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
- 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.
- Bleeding complications [ Time Frame: 72 hours ]Information on minor bleeding complications, major bleeding complications, and need for blood product transfusions will be collected.
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
|Contact: Thomas A Golper, MD||(615) firstname.lastname@example.org|
|Contact: Mohammed Sika, PhD||(615) email@example.com|
|United States, Tennessee|
|Vanderbilt University Medical Center||Recruiting|
|Nashville, Tennessee, United States, 37232|
|Contact: Thomas A Golper, MD 615-343-2220 firstname.lastname@example.org|
|Contact: Mohammed Sika, PhD (615) 936-2630 email@example.com|
|Principal Investigator: Thomas A Golper, MD|
|Principal Investigator:||Thomas A Golper, MD||Vanderbilt University|