NCT02079064

Brief Summary

The aim of this prospective randomized study is to evaluate the perioperative effects of inhalational anesthesia (desflurane) and intravenous anesthesia (propofol) on hemostasis in patients undergoing splenectomy with liver cirrhosis guided by the new technology (ROTEM) and the traditional laboratory hemostatic markers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 5, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

October 11, 2017

Status Verified

October 1, 2016

Enrollment Period

3.4 years

First QC Date

February 27, 2014

Last Update Submit

October 10, 2017

Conditions

Status; Splenectomy

Keywords

SplenectomyDesfluranePropofolTCIROTEM

Outcome Measures

Primary Outcomes (1)

  • maximum clot firmness (MCF)

    Ultimate strength and stability of the fibrin clot measured by ROTEM.

    Up to 1 month

Secondary Outcomes (9)

  • clotting time CT

    Up to 1 month

  • clot formation time; CFT

    Up to 1 month

  • D dimer

    Up to 1 month

  • Platelet count

    Up to 1 month

  • Prothrombin Time

    Pre-operative, after ligation of splenic artery, immediate post-operative, 24 hours and three days after operation

  • +4 more secondary outcomes

Study Arms (2)

Desflurane

EXPERIMENTAL

Desflurane at 1 MAC and

Drug: Desflurane

propofol

EXPERIMENTAL

propofol TCI (target controlled infusion) infusion of to keep a target plasma concentration between 2 and 5 µg ml-1

Drug: Propofol

Interventions

DesfluraneDRUG

Inhalational anesthetic

Also known as: Suprane
Desflurane
PropofolDRUG

Intravenous anesthetic that can be given by continuous infusion

Also known as: Diprivan
propofol

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patient ASA physical status II and III.
  • Age between 22-55 years.
  • Child A suffering from pancytopenia.
  • Type of surgery: splenectomy

You may not qualify if:

  • Patients using oral anticoagulants
  • Patients using antithrombotic drugs
  • Patients using non steroidal anti-inflammatory drugs
  • Patients using oral contraceptives
  • Age less than 25 or more than 55 years
  • Obese patients (body mass index \>35 kg m-2)
  • Pregnancy and lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Theodor Bilharz Research Institute

Giza, 12411, Egypt

Location

Related Publications (2)

  • Senzolo M, Burra P, Cholongitas E, Burroughs AK. New insights into the coagulopathy of liver disease and liver transplantation. World J Gastroenterol. 2006 Dec 28;12(48):7725-36. doi: 10.3748/wjg.v12.i48.7725.

    PMID: 17203512RESULT

  • Liangpunsakul S, Ulmer BJ, Chalasani N. Predictors and implications of severe hypersplenism in patients with cirrhosis. Am J Med Sci. 2003 Sep;326(3):111-6. doi: 10.1097/00000441-200309000-00001.

    PMID: 14501224RESULT

Related Links

MeSH Terms

Interventions

DesfluranePropofol

Intervention Hierarchy (Ancestors)

Ethyl EthersEthersOrganic ChemicalsMethyl EthersHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Officials

  • Gehan G El-Fandy, M.D.

    Theodor Bilharz Research Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesia

Study Record Dates

First Submitted

February 27, 2014

First Posted

March 5, 2014

Study Start

January 1, 2014

Primary Completion

June 1, 2017

Study Completion

July 1, 2017

Last Updated

October 11, 2017

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)