Skip to main content
OpenTrials
Completed

NCT Number: NCT04748081

The Major Bleeding Risk Following Hepatectomy

This study examined long-term incidence rates of major bleeding associated with hepatectomy. The investigators used data from Taiwan's National Health Insurance Research Database. Patients who underwent hepatectomy between 2000 and 2012 were identified by International Classification of Diseases, Ninth Revision, Clinical Modification codes. Variables including gender, age, comorbidities, and prescribed medications were matched between cases and controls. A total of 1,053 patients with hepatectomy and 4,212 matched non-hepatectomy subjects were included in this study.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

China Medical University Hospital

Taichung, 404, Taiwan

About this study

The study population consisted of two cohorts. Patients who underwent hepatectomy (ICD-9-CM procedure code: 50.2, 50.22, 50.3 and 50.4) between 2000 and 2012 were identified as the surgery cohort. The index date was defined as the earliest date that patients underwent hepatectomy. Patients without any record of hepatectomy during the same period of time were defined as the control cohort. Patients younger than 20 years of age and those diagnosed with coagulation defects (ICD-9-CM: 286.4) or had a pre-existing bleeding episode before the index date. The primary outcome of this study was an incident diagnosis of major bleeding, consisting of 3 categories: intracranial bleeding (ICD-9-CM; 430, 431, 432.0, 432.1, 432.9, 852.0, 852.2, 852.4, 853.0), gastrointestinal (GI) bleeding (ICD-9-CM; 456.0, 456.20, 530.7, 531, 531.2, 531.4, 531.6, 532, 532.2, 532.4, 532.6, 533, 533.2, 533.4, 533.6, 534, 534.2, 534.4, 534.6, 535.01, 535.11, 535.21, 535.31, 535.41, 535.51, 535.61, 535.71, 537.83, 537.84, 562.02, 562.03, 562.12, 562.13, 569.3, 569.85, 578) and other sites bleeding [ICD-9-CM; 336.1, 363.6, 372.72, 376.32, 377.42, 379.23 (eye); 593.81, 866.01, 866.02, 866.11, 866.12 (kidney); 719.1 (joint); 729.92 (soft tissue); 423.0 (heart); 772.5 (adrenal gland), 626.8, 626.9 (uterine)].

Demographic characteristics evaluated in this study included gender, age, comorbidities and prescribed medications. The comorbidities included hypertension (ICD-9-CM; 401-405, A260 and A269), hyperlipidemia (ICD-9-CM: 272), chronic liver disease (ICD-9-CM: 571.4, 571.5), hepatitis C virus (HCV) infection (ICD-9-CM: 070.41, 070.44, 070.51, 070.54, and V02.62), malignant neoplasm of liver and intrahepatic bile ducts (ICD-9-CM: 155), cirrhosis (ICD-9-CM: 571, A347), chronic kidney disease (ICD-9-CM: 580-589, A350), alcohol-related disease (ICD-9-CM: 291, 303, 305.0, 357.5, 425.5, 535.3, 571.0-571.3, 980.0, E947.3), biliary stone disease (ICD-9-CM: 574), and diabetes mellitus (ICD-9-CM: 250). The investigators also searched the clinical records for the use of anticoagulants, antiplatelets, thrombolytic agents, non-steroidal anti-inflammatory drugs (NSAIDs), serotonin-norepinephrine reuptake inhibitors (SNRIs) and selective serotonin reuptake inhibitors (SSRIs) prescribed before the index date. The investigators applied a 4:1 propensity-score matched analysis to reduce selection bias between cases and controls.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who underwent hepatectomy between 2000 and 2012.

Exclusion criteria

  • Patients younger than 20 years of age
  • Patients diagnosed with coagulation defects or had a pre-existing bleeding episode before the earliest date that patients underwent hepatectomy.

Treatment and study plan

Hepatectomy

Procedure

hepatectomy (ICD-9-CM procedure code: 50.2, 50.22, 50.3 and 50.4)

Primary outcomes

  1. Incident diagnosis of major bleeding

    Time frame: From the the earliest date that patients underwent hepatectomy to the date of an incident diagnosis of major bleeding, December 31, 2015 or withdraw from National Health Insurance Research Database (NHIRD).

    Major bleeding consists of 3 categories: intracranial bleeding (ICD-9-CM; 430, 431, 432.0, 432.1, 432.9, 852.0, 852.2, 852.4, 853.0), gastrointestinal (GI) bleeding (ICD-9-CM; 456.0, 456.20, 530.7, 531, 531.2, 531.4, 531.6, 532, 532.2, 532.4, 532.6, 533, 533.2, 533.4, 533.6, 534, 534.2, 534.4, 534.6, 535.01, 535.11, 535.21, 535.31, 535.41, 535.51, 535.61, 535.71, 537.83, 537.84, 562.02, 562.03, 562.12, 562.13, 569.3, 569.85, 578) and other sites bleeding [ICD-9-CM; 336.1, 363.6, 372.72, 376.32, 377.42, 379.23 (eye); 593.81, 866.01, 866.02, 866.11, 866.12 (kidney); 719.1 (joint); 729.92 (soft tissue); 423.0 (heart); 772.5 (adrenal gland), 626.8, 626.9 (uterine)].

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Collaborators

  • An-Nan Hospital, China Medical University
  • Ministry of Health and Welfare, Taiwan

Registry information

Official study title

Evaluation of the Bleeding Risk Associated With Hepatectomy: a Nationwide Population-based Study

Important dates

Study start
2000
Primary completion
2012
Study completion
2018
First posted
Feb 10, 2021
Registry last updated
Feb 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.