Antithrombin III for portal vein thrombosis in patients with liver disease

A randomized, double-blind, controlled trial

The NPB-06 study group

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

Aim: Portal vein thrombosis (PVT) is one of the most critical disorders in liver disease patients. These patients have the imbalance of coagulation and coagulation inhibition resulting from decreased levels of coagulation inhibitory factors, such as protein C, protein S, and antithrombin III (AT-III). We designed this randomized, double-blind, placebo-controlled trial comparing the safety and efficacy of AT-III for PVT in liver disease patients with those who received no treatment. Methods: Eligible patients were diagnosed with the association of thrombus, without tumor thrombus, and thrombus in more than 50% of the cross-sectional lumen of the portal vein. Patients with 70% or less serum level of AT-III were included. The study drug was given up to three times in a 5-day consecutive infusion interval if the thrombus decreased in size. Efficacy was evaluated by contrast enhanced computed tomography using a five-grade scale (complete response, partial response, slight response, no response, and progression). From October 2014 through to March 2016, 36 patients were randomly assigned to the AT-III group and 37 patients to the placebo group. Results: The proportion of patients with complete response or partial response of PVT was significantly higher in the AT-III group (55.6%; 20/36 patients; 95% confidence interval, 38.1–72.1) than in the placebo group (19.4%; 7/36 patients, 95% confidence interval, 8.2–36.0) (P = 0.003). The overall incidence of adverse events and adverse drug reactions did not differ significantly between the two groups. Conclusion: Antithrombin III is one of the essential therapies for patients with PVT in cases with lower concentration levels of AT-III.

Original languageEnglish
Pages (from-to)E107-E116
JournalHepatology Research
Volume48
Issue number3
DOIs
Publication statusPublished - Feb 1 2018

Fingerprint

Antithrombin III
Portal Vein
Liver Diseases
Thrombosis
Placebos
Confidence Intervals
Blood Coagulation Factors
Protein S
Protein C
Drug-Related Side Effects and Adverse Reactions
Tomography
Safety

All Science Journal Classification (ASJC) codes

  • Hepatology
  • Infectious Diseases

Cite this

Antithrombin III for portal vein thrombosis in patients with liver disease : A randomized, double-blind, controlled trial. / The NPB-06 study group.

In: Hepatology Research, Vol. 48, No. 3, 01.02.2018, p. E107-E116.

Research output: Contribution to journalArticle

@article{61ed11c38b9f42dc9e280034f7e7a49b,
title = "Antithrombin III for portal vein thrombosis in patients with liver disease: A randomized, double-blind, controlled trial",
abstract = "Aim: Portal vein thrombosis (PVT) is one of the most critical disorders in liver disease patients. These patients have the imbalance of coagulation and coagulation inhibition resulting from decreased levels of coagulation inhibitory factors, such as protein C, protein S, and antithrombin III (AT-III). We designed this randomized, double-blind, placebo-controlled trial comparing the safety and efficacy of AT-III for PVT in liver disease patients with those who received no treatment. Methods: Eligible patients were diagnosed with the association of thrombus, without tumor thrombus, and thrombus in more than 50{\%} of the cross-sectional lumen of the portal vein. Patients with 70{\%} or less serum level of AT-III were included. The study drug was given up to three times in a 5-day consecutive infusion interval if the thrombus decreased in size. Efficacy was evaluated by contrast enhanced computed tomography using a five-grade scale (complete response, partial response, slight response, no response, and progression). From October 2014 through to March 2016, 36 patients were randomly assigned to the AT-III group and 37 patients to the placebo group. Results: The proportion of patients with complete response or partial response of PVT was significantly higher in the AT-III group (55.6{\%}; 20/36 patients; 95{\%} confidence interval, 38.1–72.1) than in the placebo group (19.4{\%}; 7/36 patients, 95{\%} confidence interval, 8.2–36.0) (P = 0.003). The overall incidence of adverse events and adverse drug reactions did not differ significantly between the two groups. Conclusion: Antithrombin III is one of the essential therapies for patients with PVT in cases with lower concentration levels of AT-III.",
author = "{The NPB-06 study group} and Hisashi Hidaka and Shigehiro Kokubu and Takahiro Sato and Shinji Katsushima and Namiki Izumi and Takumi Igura and Shingo Asahara and Kazuo Notsumata and Yukio Osaki and Keiji Tsuji and Hirofumi Kawanaka and Tomohiko Akahoshi and Shozo Hirota and Shoichi Matsutani",
year = "2018",
month = "2",
day = "1",
doi = "10.1111/hepr.12934",
language = "English",
volume = "48",
pages = "E107--E116",
journal = "Hepatology Research",
issn = "1386-6346",
publisher = "Wiley-Blackwell",
number = "3",

}

TY - JOUR

T1 - Antithrombin III for portal vein thrombosis in patients with liver disease

T2 - A randomized, double-blind, controlled trial

AU - The NPB-06 study group

AU - Hidaka, Hisashi

AU - Kokubu, Shigehiro

AU - Sato, Takahiro

AU - Katsushima, Shinji

AU - Izumi, Namiki

AU - Igura, Takumi

AU - Asahara, Shingo

AU - Notsumata, Kazuo

AU - Osaki, Yukio

AU - Tsuji, Keiji

AU - Kawanaka, Hirofumi

AU - Akahoshi, Tomohiko

AU - Hirota, Shozo

AU - Matsutani, Shoichi

PY - 2018/2/1

Y1 - 2018/2/1

N2 - Aim: Portal vein thrombosis (PVT) is one of the most critical disorders in liver disease patients. These patients have the imbalance of coagulation and coagulation inhibition resulting from decreased levels of coagulation inhibitory factors, such as protein C, protein S, and antithrombin III (AT-III). We designed this randomized, double-blind, placebo-controlled trial comparing the safety and efficacy of AT-III for PVT in liver disease patients with those who received no treatment. Methods: Eligible patients were diagnosed with the association of thrombus, without tumor thrombus, and thrombus in more than 50% of the cross-sectional lumen of the portal vein. Patients with 70% or less serum level of AT-III were included. The study drug was given up to three times in a 5-day consecutive infusion interval if the thrombus decreased in size. Efficacy was evaluated by contrast enhanced computed tomography using a five-grade scale (complete response, partial response, slight response, no response, and progression). From October 2014 through to March 2016, 36 patients were randomly assigned to the AT-III group and 37 patients to the placebo group. Results: The proportion of patients with complete response or partial response of PVT was significantly higher in the AT-III group (55.6%; 20/36 patients; 95% confidence interval, 38.1–72.1) than in the placebo group (19.4%; 7/36 patients, 95% confidence interval, 8.2–36.0) (P = 0.003). The overall incidence of adverse events and adverse drug reactions did not differ significantly between the two groups. Conclusion: Antithrombin III is one of the essential therapies for patients with PVT in cases with lower concentration levels of AT-III.

AB - Aim: Portal vein thrombosis (PVT) is one of the most critical disorders in liver disease patients. These patients have the imbalance of coagulation and coagulation inhibition resulting from decreased levels of coagulation inhibitory factors, such as protein C, protein S, and antithrombin III (AT-III). We designed this randomized, double-blind, placebo-controlled trial comparing the safety and efficacy of AT-III for PVT in liver disease patients with those who received no treatment. Methods: Eligible patients were diagnosed with the association of thrombus, without tumor thrombus, and thrombus in more than 50% of the cross-sectional lumen of the portal vein. Patients with 70% or less serum level of AT-III were included. The study drug was given up to three times in a 5-day consecutive infusion interval if the thrombus decreased in size. Efficacy was evaluated by contrast enhanced computed tomography using a five-grade scale (complete response, partial response, slight response, no response, and progression). From October 2014 through to March 2016, 36 patients were randomly assigned to the AT-III group and 37 patients to the placebo group. Results: The proportion of patients with complete response or partial response of PVT was significantly higher in the AT-III group (55.6%; 20/36 patients; 95% confidence interval, 38.1–72.1) than in the placebo group (19.4%; 7/36 patients, 95% confidence interval, 8.2–36.0) (P = 0.003). The overall incidence of adverse events and adverse drug reactions did not differ significantly between the two groups. Conclusion: Antithrombin III is one of the essential therapies for patients with PVT in cases with lower concentration levels of AT-III.

UR - http://www.scopus.com/inward/record.url?scp=85027126490&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85027126490&partnerID=8YFLogxK

U2 - 10.1111/hepr.12934

DO - 10.1111/hepr.12934

M3 - Article

VL - 48

SP - E107-E116

JO - Hepatology Research

JF - Hepatology Research

SN - 1386-6346

IS - 3

ER -