Anticoagulation, Hemodialysis
Conditions
Brief summary
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
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.
Interventions
DRUGtwo 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.
DRUGone 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.
Sponsors
Guangdong Provincial People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| therapy interruption event | through study completion, from start to four hours | visible serious circuit clotting or persistent alarms such as venous pressure (\> 200 mmHg) or TMP (\> 300 mmHg)dialyzer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the clotting scores | through study procedure,an average of four hours | the clotting scores in the venous expansion chamber, arterial expansion chamber and dialyzer |
| urea clearance | through study procedure,an average of four hours | the measurement of Kt/V and URR |
Countries
China
Contacts
Primary ContactXinling Liang, Ph.D.,M.D.
Backup ContactTing Lin, Ph.D.,M.D.
Outcome results
None listed