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

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ClinicalTrials.gov Identifier: NCT03419923
Recruitment Status : Recruiting
First Posted : February 2, 2018
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Guangdong General Hospital

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.

Condition or disease Intervention/treatment Phase
Hemodialysis Anticoagulation Drug: two stage regional citrate Drug: one stage regional citrate Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 141 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Three Anticoagulation Strategies for Hemodialysis in Patients at Risk of Hemorrhage: a Multicenter Randomized Trial
Actual Study Start Date : September 10, 2017
Estimated Primary Completion Date : March 30, 2019
Estimated Study Completion Date : March 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Dialysis

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.




Primary Outcome Measures :
  1. therapy interruption event [ Time Frame: through study completion, from start to four hours ]
    visible serious circuit clotting or persistent alarms such as venous pressure (> 200 mmHg) or TMP (> 300 mmHg)dialyzer


Secondary Outcome Measures :
  1. the clotting scores [ Time Frame: through study procedure,an average of four hours ]
    the clotting scores in the venous expansion chamber, arterial expansion chamber and dialyzer

  2. urea clearance [ Time Frame: through study procedure,an average of four hours ]
    the measurement of Kt/V and URR



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03419923


Contacts
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Contact: Xinling Liang, Ph.D.,M.D. +8613808819770 13808819770@139.com
Contact: Ting Lin, Ph.D.,M.D. +8615013186074 linting131@163.com

Locations
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China, Guangdong
Guangdong General Hospital Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Ting Lin, Ph.D.,M.D.    +8615013186074    linting131@163.com   
Sponsors and Collaborators
Guangdong General Hospital
Investigators
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Study Director: Liming Yao, M.D. Guangdong General Hospital

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Responsible Party: Guangdong General Hospital
ClinicalTrials.gov Identifier: NCT03419923     History of Changes
Other Study ID Numbers: GDREC2017250H
First Posted: February 2, 2018    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes
Citric Acid
Sodium Citrate
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action