Clinical trial NCT03419923: Three Anticoagulation Strategies for Hemodialysis in Patients at Risk of Hemorrhage
Official title: Three Anticoagulation Strategies for Hemodialysis in Patients at Risk of Hemorrhage: a Multicenter Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemodialysis
Anticoagulation
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: therapy interruption event
timeFrame: through study completion, from start to four hours
Secondary outcomes:
measure: the clotting scores
timeFrame: through study procedure,an average of four hours
measure: urea clearance
timeFrame: through study procedure,an average of four hours
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Liming Yao, M.D.
role: STUDY_DIRECTOR
References: