Evaluation of Coagulation Factors and Point-of-care Devices During Veno-venous ECMO Therapy

NCT03754868 | Completed

• 1 other identifier: 19/5/13
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Hemorrhagic and thromboembolic complications are common in Veno-venous ECMO therapy. The aim of this study is to provide a detailed analysis of the activity of different coagulation factors and changes in functional coagulation measurements as in rotational thrombelastometry and multiple electrode aggregometry in the course of ECMO therapy.

Conditions

Extracorporeal Membrane Oxygenation Complication; Coagulation Factor Deficiency

Keywords

ECMO; Coagulation monitoring; point-of-care

Outcome Measures

Primary Outcomes (8)

• Changes in the activity of coagulation factor II [%] during Veno-venous ECMO therapy

  Repeated assessment of the activity of coagulation factor II in % through standard coagulometric methods.

  Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation

• Changes in the activity of coagulation factor V [%] during Veno-venous ECMO

  Repeated assessment of the activity of coagulation factor V in % through standard coagulometric methods.

  Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation

• Changes in the activity of coagulation factor VII [%] during Veno-venous ECMO

  Repeated assessment of the activity of coagulation factor VII in % through standard coagulometric methods.

  Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation

• Changes in the activity of coagulation factor VIII [%] during Veno-venous ECMO

  Repeated assessment of the activity of coagulation factor VIII in % through standard coagulometric methods.

  Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation

• Changes in the activity of coagulation factor IX [%] during Veno-venous ECMO

  Repeated assessment of the activity of coagulation factor IX in % through standard coagulometric methods.

  Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation

• Changes in the activity of coagulation factor X [%] during Veno-venous ECMO

  Repeated assessment of the activity of coagulation factor X in % through standard coagulometric methods.

  Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation

• Changes in the activity of coagulation factor XII [%] during Veno-venous ECMO

  Repeated assessment of the activity of coagulation factor XII in % through standard coagulometric methods.

  Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation

• Changes in the activity of coagulation factor XIII [%] during Veno-venous ECMO

  Repeated assessment of the activity of coagulation factor XIII in % through standard coagulometric methods.

  Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation

Secondary Outcomes (35)

• vWF-Antigen

  Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation

• Changes in the vWF:Ristocetin-Cofaktor-Activity in % during Veno-venous ECMO therapy

  Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation

• Changes in CT-EXTEM

  Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation

• Changes in CT-INTEM

  Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation

• Changes in CT-FIBTEM

  Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation

Interventions

Detailed coagulation monitoring DIAGNOSTIC_TEST

Monitoring of coagulation using activity of coagulation factors, rotational thrombelastometry and multiple electrode aggregometry

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with the need for Veno-venous ECMO therapy treated in a tertiary intensive care unit.

You may qualify if:

• Need for a Veno-venous extracorporeal membrane oxygenation therapy

You may not qualify if:

• Known coagulation disorders
• Refusal to participate

Sponsors & Collaborators

• University Hospital Goettingen: lead

Study Sites (1)

University Medical Center Goettingen

Göttingen, 37075, Germany

Location

Study Officials

• Onnen Moerer, Prof.

  Department of Anesthesiology, University Medical Center Goettingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident for Anesthesiology, Principal Investigator

Study Record Dates

• First Submitted: November 7, 2018
• First Posted: November 27, 2018
• Study Start: July 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: November 27, 2018

Record last verified: 2018-11

Locations

DE (1)