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The Major Bleeding Risk Following Hepatectomy

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ClinicalTrials.gov Identifier: NCT04748081
Recruitment Status : Completed
First Posted : February 10, 2021
Last Update Posted : February 10, 2021
Sponsor:
Collaborators:
An-Nan Hospital, China Medical University
Ministry of Health and Welfare, Taiwan
Information provided by (Responsible Party):
China Medical University Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Gastrointestinal Hemorrhage Postoperative Hemorrhage Surgery--Complications Procedure: hepatectomy

Detailed 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.

Study Design
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Study Type : Observational
Actual Enrollment : 5265 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation of the Bleeding Risk Associated With Hepatectomy: a Nationwide Population-based Study
Actual Study Start Date : January 1, 2000
Actual Primary Completion Date : December 31, 2012
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Groups and Cohorts
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Group/Cohort Intervention/treatment
Surgery cohort
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.
 Procedure: hepatectomy
hepatectomy (ICD-9-CM procedure code: 50.2, 50.22, 50.3 and 50.4)
Control cohort
Patients without any record of hepatectomy between 2000 and 2012 were defined as the control cohort.


Outcome Measures
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Primary Outcome Measures :
  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)].


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients who underwent hepatectomy (ICD-9-CM procedure code: 50.2, 50.22, 50.3 and 50.4) between 2000 and 2012, and without past history of coagulation defects and bleeding episodes.
Criteria

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.
Contacts and Locations
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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): NCT04748081


Locations
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Taiwan
China Medical University Hospital
Taichung, Taiwan, 404
Sponsors and Collaborators
China Medical University Hospital
An-Nan Hospital, China Medical University
Ministry of Health and Welfare, Taiwan
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT04748081    
Other Study ID Numbers: CMUH104-REC2-115
First Posted: February 10, 2021    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: February 2021
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
Keywords provided by China Medical University Hospital:
Gastrointestinal hemorrhage
Hepatectomy
Postoperative hemorrhage
Additional relevant MeSH terms:
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Gastrointestinal Hemorrhage
Hemorrhage
Postoperative Hemorrhage
Pathologic Processes
 Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications