Trial Outcomes & Findings for A Comparison of Dilute Versus Concentrated Heparin for CRRT Anticoagulation (NCT NCT01318811)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

12 participants

Primary outcome timeframe

72 hours

Results posted on

2019-02-22

Participant Flow

Participant milestones

Participant milestones
Measure	Dilute Heparin Arm B will receive dilute heparin delivered as an intravenous infusion proximal to the dialysis filter. 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.	Standard Concentrated Heparin Arm A will receive standard concentrated heparin and will be delivered as an intravenous infusion proximal to the dialysis filter. 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.
Overall Study STARTED	4	8
Overall Study COMPLETED	3	4
Overall Study NOT COMPLETED	1	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Dilute Heparin Arm B will receive dilute heparin delivered as an intravenous infusion proximal to the dialysis filter. 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.	Standard Concentrated Heparin Arm A will receive standard concentrated heparin and will be delivered as an intravenous infusion proximal to the dialysis filter. 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.
Overall Study Physician Decision	1	1
Overall Study CRRT stopped for head CT	0	1
Overall Study Death	0	1
Overall Study CRRT stopped for head MRI	0	1

Baseline Characteristics

A Comparison of Dilute Versus Concentrated Heparin for CRRT Anticoagulation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dilute Heparin n=4 Participants Arm A will receive dilute heparin delivered as an intravenous infusion proximal to the dialysis filter. 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.	Standard Concentrated Heparin n=8 Participants Arm B will receive standard concentrated heparin and will be delivered as an intravenous infusion proximal to the dialysis filter. 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.	Total n=12 Participants Total of all reporting groups
Age, Continuous	58.25 years STANDARD_DEVIATION 16.5 • n=5 Participants	57.5 years STANDARD_DEVIATION 11 • n=7 Participants	57.75 years STANDARD_DEVIATION 12.75 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	8 participants n=7 Participants	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 72 hours

Population: analysis does not include those that had dialysis stopped before end of filter life

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.

Outcome measures

Outcome measures
Measure	Dilute Heparin n=3 Participants Arm A will receive dilute heparin delivered as an intravenous infusion proximal to the dialysis filter. 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.	Standard Concentrated Heparin n=4 Participants Arm B will receive standard concentrated heparin and will be delivered as an intravenous infusion proximal to the dialysis filter. 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.
Filter Life	22.46 hours Standard Deviation 3.32	33 hours Standard Deviation 22.22

SECONDARY outcome

Timeframe: 72 hours

Population: includes all that started study

Information on major bleeding complications, and need for blood product transfusions will be collected.

Outcome measures

Outcome measures
Measure	Dilute Heparin n=4 Participants Arm A will receive dilute heparin delivered as an intravenous infusion proximal to the dialysis filter. 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.	Standard Concentrated Heparin n=8 Participants Arm B will receive standard concentrated heparin and will be delivered as an intravenous infusion proximal to the dialysis filter. 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.
Number of Major Bleeding Complications	0 clinical active major bleeding episodes	0 clinical active major bleeding episodes

Adverse Events

Dilute Heparin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Standard Concentrated Heparin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 4 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Thomas Golper

Vanderbilt_Univeristy MC

Phone: 615-322-5914

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place