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

December 23, 2017 updated by: Mostafa Samy Abbas, Assiut University
To evaluate the effects of Terlipressin infusion on blood loss & transfusion requirements in cirrhotic patients undergoing major liver resections.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Asyut Governorate
      • Assiut, Asyut Governorate, Egypt, 11111
        • Assiut University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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(1 mg over 30 mins) followed by a continuous infusion of 2μg/kg/h to be continued throughout the surgery then gradually withdrawn over 4 hours
Drug: 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.
Other Names:
  • glipressin
Placebo Comparator: Control
same volumes of normal saline with the same rate of infusion, throughout the operation then gradually withdrawn over 4 hours.
Drug: normal saline
Same volumes of normal saline infusion, throughout the operation then gradually withdrawn over 4 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood loss
Time Frame: intraoperative period
blood loss in ml
intraoperative period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood units transfused
Time Frame: intraoperative period
number of packed RBCs units transfused
intraoperative period
lactate level
Time Frame: at start and end of resection
lactate level in blood gas sample in mmol/L
at start and end of resection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

October 26, 2015

First Submitted That Met QC Criteria

October 27, 2015

First Posted (Estimate)

October 28, 2015

Study Record Updates

Last Update Posted (Actual)

December 27, 2017

Last Update Submitted That Met QC Criteria

December 23, 2017

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Terlipressin

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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