Three Anticoagulation Strategies for Hemodialysis in Patients at Risk of Hemorrhage

Study Overview
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Brief Summary
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The aim of our study is to assess three anticoagulation strategies for intermittent hemodialysis(IHD) in patients at risk of hemorrhage. A registry of consecutive hemodialysis patients with high risk of hemorrhage was conducted at the Guangdong General Hospital, the First Affiliated Hospital of Guangzhou University of Chinese Medicine, the Second Affiliated Hospital of Guangzhou Medicine University or Guangzhou Hospital of Chinese Medicine, between Sep 10, 2017 and June 30th,2018. In this multi-center prospective and randomized study, participants were randomly divided into three groups during IHD according to different anticoagulation, including with regular saline flushes, one stage regional citrate anticoagulation (RCA) and two-stage RCA.

Detailed Description
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Briefly, there are two parts in this study. The first part of the study is to compare two-stage RCA with one stage RCA during IHD, and the second part is to compare two-stage RCA with regular saline flushes, with estimated total procedures, 78 and 48, respectively. The primary outcome was measured as therapy interruption based on visible serious circuit clotting or persistent alarms such as venous pressure (> 200 mmHg) or TMP(transmembrane pressures) (> 300 mmHg). The secondary outcomes included circuit survival time, the total clotting score of ECC(extracorporeal circuit ) and urea clearance (Kt/V and URR). The total clotting score was the sum of the clotting scores for the venous expansion chamber, arterial expansion chamber, and dialyzer.

Official Title
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Three Anticoagulation Strategies for Hemodialysis in Patients at Risk of Hemorrhage: a Multicenter Randomized Trial

Conditions
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Hemodialysis, Anticoagulation

Intervention / Treatment
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* Drug: two stage regional citrate
* Drug: one stage regional citrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age>=18 years intermittent hemodialysis patients that carry on a 4 hours hemodialysis procedure, 2-3 times one week. the therapy mode is hemodialysis，with a dialysis fluid more than 500ml/min and blood flow volume more than 3.5-4ml/min.kg； at risk of hemorrhage,including active hemorrhage(within 3 days),post-operation(within 3 days) and pre-invasive operation(within 7 days). Exclusion Criteria: at high risk of citrate accumulation( total bilirubin >60umol/L; lactic acid>3mmol/L,）； use the drugs that impact the coagulation function within 7 days; serious hypocalcemia (serum calcium<1.9mmol/L).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: saline flushes<br>saline flushes with 250 mL were carried out every 30 min. | Drug: two stage regional citrate<br>* 4% trisodium citrate was infused at the arterial bubble trap at a rate according to the blood flow(3/4 x 1.2 x blood flow)ml/h,and at the venous bubble trap at a rate according to the blood flow(1/4 x 1.2 x blood flow)ml/h.<br>|
| Active Comparator: one stage regional citrate<br>one stage regional citrate:4% trisodium citrate was infused at the arterial bubble trap at a rate according to the blood flow( 1.2 x blood flow)ml/h. | Drug: one stage regional citrate<br>* 4% trisodium citrate was infused at the arterial bubble trap at a rate according to the blood flow( 1.2 x blood flow)ml/h.<br>|
| Experimental: two stage regional citrate<br>two stage regional citrate:4% trisodium citrate was infused at the arterial bubble trap at a rate according to the blood flow(3/4 x 1.2 x blood flow)ml/h,and at the venous bubble trap at a rate according to the blood flow(1/4 x 1.2 x blood flow)ml/h. | Drug: two stage regional citrate<br>* 4% trisodium citrate was infused at the arterial bubble trap at a rate according to the blood flow(3/4 x 1.2 x blood flow)ml/h,and at the venous bubble trap at a rate according to the blood flow(1/4 x 1.2 x blood flow)ml/h.<br>Drug: one stage regional citrate<br>* 4% trisodium citrate was infused at the arterial bubble trap at a rate according to the blood flow( 1.2 x blood flow)ml/h.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| therapy interruption event | visible serious circuit clotting or persistent alarms such as venous pressure (> 200 mmHg) or TMP (> 300 mmHg)dialyzer | through study completion, from start to four hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the clotting scores | the clotting scores in the venous expansion chamber, arterial expansion chamber and dialyzer | through study procedure,an average of four hours | 
| urea clearance | the measurement of Kt/V and URR | through study procedure,an average of four hours |