NCT02356068

Brief Summary

Patients with cirrhosis present complex coagulation defects. Conventional coagulation tests (INR, platelets count) can not predict bleeding or blood product requirements during liver transplantation. Thromboelastometry (TEM)analyser measures the viscoelastic of the whole blood coagulation generation and lysis. TEM results are available more rapidly than conventional tests and give additional information regarding coagulation strengh, platelet function, and fibrinolysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2015

Typical duration for all trials

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, 2015

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 5, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

July 24, 2020

Status Verified

February 1, 2018

Enrollment Period

3.1 years

First QC Date

January 24, 2015

Last Update Submit

July 22, 2020

Conditions

Hemorrhage

Keywords

liver transplantation, rotem, bleeding, transfusion

Outcome Measures

Primary Outcomes (1)

  • bleeding and transfusion

    evaluation of bleeding and transfusion peroperatively and 24 hours post-op.

    24 hours

Study Arms (1)

liver transplantation recepient

every patient who had a liver transplantation. 3 blood samples (2.7ml) for the ROTEM analysis

Other: ROTEM analysis

Interventions

ROTEM analysisOTHER

3 blood samples for ROTEM analysis

liver transplantation recepient

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

every patient who had a liver transplantation

You may qualify if:

  • every patient who had a liver transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

Location

Related Publications (1)

  • Carrier FM, Denault AY, Nozza A, Rioux-Masse B, Roy A, Massicotte L. Association between intraoperative rotational thromboelastometry or conventional coagulation tests and bleeding in liver transplantation: an observational exploratory study. Anaesth Crit Care Pain Med. 2020 Dec;39(6):765-770. doi: 10.1016/j.accpm.2020.07.018. Epub 2020 Oct 1.

    PMID: 33011332DERIVED

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Luc Massicotte, Doctor

    CrCHUM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Week
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2015

First Posted

February 5, 2015

Study Start

January 1, 2015

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

July 24, 2020

Record last verified: 2018-02

Locations

CA(1)