Massive Transfusion Protocol With Coagulation Algorithm

Bleeding Clinical Trial

Official title:

Introduction of a Massive Transfusion Protocol - Evaluation Over Three Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02350101
• Other study ID #: KEK-ZH-Nr. 2010-0234/4
• Status: Completed
• Phase: N/A
• First received: January 16, 2015
• Last updated: January 23, 2015
• Start date: January 2010
• Est. completion date: December 2012

Study information

• Verified date: January 2015
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Federal Office of Public Health
• Study type: Observational

Clinical Trial 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.

Description:

In 2008 at the USZ a massive transfusion protocol was introduced. Based on laboratory diagnostics and POC (point of care) 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 over three years (2008-2010)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Massive transfusion

Exclusion Criteria:

• non

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Bleeding

Intervention

Device:
• Rotational thromboelastometry
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Transfusion needs	To evaluate the blood products and coagulation factors needed and to evaluate if there is a reduction between the time before the introduction of the algorithm compared to afterwards.	3 years	No