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

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

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.

Study Overview

• Status: Unknown
• Conditions: Hemodialysis; Anticoagulation
• Intervention / Treatment: Drug: two stage regional citrate; Drug: one stage regional citrate

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.

• Study Type: Interventional
• Enrollment (Anticipated): 141
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • Guangdong General Hospital
      • Contact: Ting Lin, Ph.D.,M.D.; Phone Number: +8615013186074; Email: linting131@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: saline flushes; saline flushes with 250 mL were carried out every 30 min.	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.
Active Comparator: one stage regional citrate; 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; 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.
Experimental: two stage regional citrate; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Guangdong Provincial People's Hospital
• Investigators: Study Director: Liming Yao, M.D., Guangdong Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2017
• Primary Completion (Anticipated): March 30, 2019
• Study Completion (Anticipated): March 30, 2019

Study Registration Dates

• First Submitted: January 11, 2018
• First Submitted That Met QC Criteria: January 31, 2018
• First Posted (Actual): February 5, 2018

Study Record Updates

• Last Update Posted (Actual): December 12, 2018
• Last Update Submitted That Met QC Criteria: December 11, 2018
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Molecular Mechanisms of Pharmacological Action; Anticoagulants; Chelating Agents; Sequestering Agents; Calcium Chelating Agents; Citric Acid; Sodium Citrate
• Other Study ID Numbers: GDREC2017250H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No