Three Anticoagulation Strategies for Hemodialysis in Patients at Risk of Hemorrhage (TASHA)

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status: Unknown

Conditions: Hemodialysis; Anticoagulation

Treatments: Drug: one stage regional citrate; Drug: two stage regional citrate

Study type: Interventional

Funder types: Other

Identifiers

NCT03419923

GDREC2017250H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 141 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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141 participants in 3 patient groups, including a placebo group

saline flushes

Placebo Comparator group

Description:

saline flushes with 250 mL were carried out every 30 min.

Treatment:

Drug: two stage regional citrate

one stage regional citrate

Active Comparator group

Description:

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.

Treatment:

Drug: one stage regional citrate

two stage regional citrate

Experimental group

Description:

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.

Treatment:

Drug: one stage regional citrate

Drug: two stage regional citrate