Three Anticoagulation Strategies for Hemodialysis in Patients at Risk of Hemorrhage

Hemodialysis Clinical Trial

— TASHA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03419923
• Other study ID #: GDREC2017250H
• Status: Recruiting
• Phase: N/A
• Start date: September 10, 2017
• Est. completion date: March 30, 2019

Study information

• Verified date: December 2017
• Source: Guangdong General Hospital
• Contact: Xinling Liang, Ph.D.,M.D.
• Phone: +8613808819770
• Email: 13808819770[@]139.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 141
• Est. completion date: March 30, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Anticoagulation
• Hemodialysis
• Hemorrhage

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Guangdong General Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	the clotting scores	the clotting scores in the venous expansion chamber, arterial expansion chamber and dialyzer	through study procedure,an average of four hours
Secondary	urea clearance	the measurement of Kt/V and URR	through study procedure,an average of four hours