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Three Anticoagulation Strategies for Hemodialysis in Patients at Risk of Hemorrhage

NCT ID: NCT03419923

Last Updated: 2018-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-10

Study Completion Date

2019-03-30

Brief Summary

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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

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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

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Hemodialysis Anticoagulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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saline flushes

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

Group Type PLACEBO_COMPARATOR

two stage regional citrate

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

one stage regional citrate

Intervention Type DRUG

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.

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.

Group Type EXPERIMENTAL

two stage regional citrate

Intervention Type DRUG

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

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangdong Provincial People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Liming Yao, M.D.

Role: STUDY_DIRECTOR

Guangdong Provincial People's Hospital

Locations

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Guangdong General Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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

Role: CONTACT

Phone: +8613808819770

Email: [email protected]

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

Role: CONTACT

Phone: +8615013186074

Email: [email protected]

Facility Contacts

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

Role: primary

References

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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.

Reference Type DERIVED
PMID: 38189593 (View on PubMed)

Other Identifiers

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GDREC2017250H

Identifier Type: -

Identifier Source: org_study_id