Hemostasis in pediatric patients undergoing orthotopic liver transplantation: a prospective cohort study.

Completed

• Conditions: coagulation; hemostasis; reducing bleeding mechanism; 10019654; 10019818

• Registration Number: NL-OMON45316
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-06-25
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

Study group
- Patients that undergo orthotopic liver transplantation for any reason at the UMCG, except patients with acute liver failure
- Livers from all sort of donors will be included, including living donor livers
- In the period from june 2017 to june 2018
- Signed informed consent (patients and/or parents/guardian);Control group
- Healthy patients that undergo minor surgery at the UMCG
Minor surgery includes inguinal operations and excision of soft tissue tumours other than malignancy, like a cyst, hemangioma or lipoma.
- In the period from june 2017 to june 2018
- Matched 2:1 with the study group population for age
- Signed informed consent (patients and/or parents/guardian)

Exclusion Criteria

Study group
- Age > 16 years
- No informed consent obtained
- Diagnose of acute liver failure;Control group
- Age > 16 years
- No informed consent obtained
- Any comorbidities or pre-term birth
- Use of medication that influences liver function or hemostasis
- History of thrombotic events or bleeding

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Routine diagnostic tests of hemostasis (platelet count, prothrombin time),<br /><br>thrombin generation tests, and thromboelastography.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable.</p><br>