The Major Bleeding Risk Following Hepatectomy

Surgery--Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04748081
• Other study ID #: CMUH104-REC2-115
• Status: Completed
• Start date: January 1, 2000
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2021
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5265
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Hemorrhage
• Postoperative Hemorrhage
• Surgery--Complications

Intervention

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

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung

Sponsors (3)

Lead Sponsor	Collaborator
China Medical University Hospital	An-Nan Hospital, China Medical University, Ministry of Health and Welfare, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incident diagnosis of major bleeding	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)].	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).