NCT03419923

Three Anticoagulation Strategies for Hemodialysis in Patients at Risk of Hemorrhage

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 141 (estimated)
• Sponsor: Guangdong Provincial People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemodialysis
• Anticoagulation

Interventions

Type	Name	Description
DRUG	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	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.

Timeline

• Start date: 2017-09-10
• Primary completion: 2019-03-30
• Completion: 2019-03-30
• First posted: 2018-02-05
• Last updated: 2018-12-12

Locations

1 site across 1 country: China