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Effects of Terlipressin on Blood Loss and Transfusion Requirements During Major Liver Resection.

NCT ID: NCT02588716

Last Updated: 2017-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-12-31

Brief Summary

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To evaluate the effects of Terlipressin infusion on blood loss \& transfusion requirements in cirrhotic patients undergoing major liver resections.

Detailed Description

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Conditions

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Hepatectomy, Surgical Blood Loss, Terlipressin

Keywords

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Hepatectomy, Surgical Blood Loss, terlipressin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Terlipressin

Terlipressin will be given at the beginning of surgery as an initial bolus dose of (1 mg over 30 mins) followed by a continuous infusion of 2μg/kg/h to be continued throughout the surgery then gradually withdrawn over 4 hours

Group Type ACTIVE_COMPARATOR

Terlipressin

Intervention Type DRUG

Terlipressin will be given as an intravenous injection of 2μg/kg/h to be continued throughout the surgery and weaned off over four hours postoperatively.

Control

same volumes of normal saline with the same rate of infusion, throughout the operation then gradually withdrawn over 4 hours.

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

Same volumes of normal saline infusion, throughout the operation then gradually withdrawn over 4 hours.

Interventions

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Terlipressin

Terlipressin will be given as an intravenous injection of 2μg/kg/h to be continued throughout the surgery and weaned off over four hours postoperatively.

Intervention Type DRUG

normal saline

Same volumes of normal saline infusion, throughout the operation then gradually withdrawn over 4 hours.

Intervention Type DRUG

Other Intervention Names

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glipressin

Eligibility Criteria

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Inclusion Criteria

* All patients older than 18 years of age, American Society of Anesthesiology (ASA) classification class I and II and assigned for elective resection of 2 or more liver segments portal hypertension

Exclusion Criteria

* Patients with Child-Turcotte-Pugh grade B or C, clinically significant portal hypertension (splenomegaly, thrombocytopenia with platelets \< 1011/L, esophageal varices grade 2 or more), Preoperative renal failure (GFR \< 50ml/min), heart failure, Bradyarrhythmia (heart rate \< 60/min), history of hemorrhagic stroke, Uncontrolled arterial hypertension (Blood pressure \>160/100mmHg), and Pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mostafa Samy Abbas

Lecturer, of Anesthesia & ICU, Assiut University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut University hospital

Asyut, Asyut Governorate, Egypt

Site Status

Countries

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Egypt

References

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Abbas MS, Mohamed KS, Ibraheim OA, Taha AM, Ibraheem TM, Fadel BA, Elawamy A, Abbas AM. Effects of terlipressin infusion on blood loss and transfusion needs during liver resection: A randomised trial. Acta Anaesthesiol Scand. 2019 Jan;63(1):34-39. doi: 10.1111/aas.13226. Epub 2018 Aug 5.

Reference Type DERIVED
PMID: 30079635 (View on PubMed)

Other Identifiers

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Terlipressin

Identifier Type: -

Identifier Source: org_study_id