NCT02299947

Brief Summary

The purpose of this study is to answer the following question: Leads a primary coagulation corrected with a single dose of fibrinogen concentrate after ascending aorta-arc reconstruction to a decrease in the number of allogenic blood transfusions, compared to placebo?

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2014

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

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

August 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 24, 2014

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2018

Completed
Last Updated

May 10, 2019

Status Verified

May 1, 2019

Enrollment Period

3.7 years

First QC Date

November 18, 2014

Last Update Submit

May 8, 2019

Conditions

HemorrhageThoracic Aneurysm

Outcome Measures

Primary Outcomes (1)

  • Number of transfused blood products

    24 hours after surgery

Secondary Outcomes (3)

  • Blood loss

    24 hours after surgery

  • Re-operation

    30 day after surgery

  • Mortality

    30 day mortality

Study Arms (2)

Haemocomplettan P

EXPERIMENTAL

Study patients that receive Haemocomplettan P

Drug: Haemocomplettan P

NaCl 0.9%

PLACEBO COMPARATOR

Study patients that receive NaCl 0.9%

Drug: Placebo

Interventions

Haemocomplettan PDRUG
Haemocomplettan P
PlaceboDRUG
NaCl 0.9%

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective surgery for thoracic aneurysm

You may not qualify if:

  • Prior trombosis or myocardial infarction, congenital coagulation disorder, use of anti-coagulants prior to surgery, prior thoracic surgery, pregnancy, pre-operative fibrinogen concentration \<1g/L

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Antonius hospital

Nieuwegein, Utrecht, 3435 CM, Netherlands

Location

MeSH Terms

Conditions

HemorrhageAortic Aneurysm, Thoracic

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsAortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Peter Noordzij, PhD

    St. Antonius Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

November 18, 2014

First Posted

November 24, 2014

Study Start

August 1, 2014

Primary Completion

April 26, 2018

Study Completion

April 26, 2018

Last Updated

May 10, 2019

Record last verified: 2019-05

Locations

NL(1)