NCT03419923

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
141

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 5, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2019

Completed
Last Updated

December 12, 2018

Status Verified

December 1, 2017

Enrollment Period

1.6 years

First QC Date

January 11, 2018

Last Update Submit

December 11, 2018

Conditions

HemodialysisAnticoagulation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • the clotting scores

    through study procedure,an average of four hours

  • urea clearance

    through study procedure,an average of four hours

Study Arms (3)

saline flushes

PLACEBO COMPARATOR

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

Drug: two stage regional citrate

one stage regional citrate

ACTIVE COMPARATOR

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

two stage regional citrate

EXPERIMENTAL

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 citrateDrug: one stage regional citrate

Interventions

two stage regional citrateDRUG

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.

saline flushestwo stage regional citrate
one stage regional citrateDRUG

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.

one stage regional citratetwo stage regional citrate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong General Hospital

Guangzhou, Guangdong, 510515, China

RECRUITING

Related Publications (1)

  • Natale P, Palmer SC, Ruospo M, Longmuir H, Dodds B, Prasad R, Batt TJ, Jose MD, Strippoli GF. Anticoagulation for people receiving long-term haemodialysis. Cochrane Database Syst Rev. 2024 Jan 8;1(1):CD011858. doi: 10.1002/14651858.CD011858.pub2.

    PMID: 38189593DERIVED

Study Officials

  • Liming Yao, M.D.

    Guangdong Provincial People's Hospital

    STUDY DIRECTOR

Central Study Contacts

Xinling Liang, Ph.D.,M.D.

CONTACT

+861380881977013808819770@139.com

Ting Lin, Ph.D.,M.D.

CONTACT

+8615013186074linting131@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2018

First Posted

February 5, 2018

Study Start

September 10, 2017

Primary Completion

March 30, 2019

Study Completion

March 30, 2019

Last Updated

December 12, 2018

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)