NCT02350101

Brief Summary

In 2008 at the University Hospital Zurich (USZ) a massive transfusion protocol was introduced. Based on laboratory diagnostics and point of care (POC) devices including ROTEM. Goal of this retrospective study is to evaluate the influence of this algorithm on coagulation, use of blood products, coagulation factors and ROTEM evolution.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
243

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Typical duration for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 29, 2015

Completed
Last Updated

January 29, 2015

Status Verified

January 1, 2015

Enrollment Period

2.9 years

First QC Date

January 16, 2015

Last Update Submit

January 23, 2015

Conditions

Bleeding

Outcome Measures

Primary Outcomes (1)

  • Coagulation in ROTEM

    Point of care devices are used in bleeding patients. In the university hospital of Zurich an algorithm in the case of massive bleeding was introduced in 2008. The primary outcome measure is to investigate the changes of ROTEM parameters in the sense of amelioration reflected by better coagulation by using goal directed transfusions.

    3 years

Secondary Outcomes (1)

  • Transfusion needs

    3 years

Interventions

Rotational thromboelastometryDEVICE

In bleeding patients point of care measurements are performed, in this case Rotational Thromboelastometry (ROTEM) to guide the use of blood products and coagulation factors.

Eligibility Criteria

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

All patients needing massive transfusion (more than 10 RBCs)

You may qualify if:

  • Massive transfusion

You may not qualify if:

  • non

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr med

Study Record Dates

First Submitted

January 16, 2015

First Posted

January 29, 2015

Study Start

January 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

January 29, 2015

Record last verified: 2015-01