NCT01008436

Brief Summary

The study enrolles all consecutive patients undergoing cardiac surgery at the European Hospital, Rome. The population undergoes randomization to receive usual surgical hemostasis or added topical application of Omni-stat Celox. The two populations are followed up prospectively as regarding blood loss and need for blood transfusions, as well as adverse events at 30 days after surgery.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 5, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

February 22, 2012

Status Verified

February 1, 2012

Enrollment Period

7 months

First QC Date

November 3, 2009

Last Update Submit

February 19, 2012

Conditions

Hemostasis

Keywords

Ability of topical drug to reduce acute and overall bleeding as well as blood transfusions

Outcome Measures

Primary Outcomes (2)

  • Number of blood units transfused to the patients after surgery till discharge

    30 days

  • Percentage of acute bleeding controlled by Hemostasis Tool (surgical technique or Omnistat application) in the defined time frame of 10 minutes

    10 minutes

Secondary Outcomes (2)

  • Blood volume collected in chest drains expressed in milliliters, with partial totals 3, 6 and 12 hours after surgery and final total 24 hours after surgery.

    3, 6, 12, 24 hours

  • Time needed to achieve Hemostasis using Omnistat as regarding to defined time frames of 1,2,3,5,7,10 minutes

    1,2,3,5,7,10 minutes after application

Study Arms (2)

Control

ACTIVE COMPARATOR

Traditional best-practice surgical hemostasis

Drug: Control

Omni-stat Celox

EXPERIMENTAL

Administration of 6 gr of Omni-stat Celox intraoperatively at the time of Hemostasis

Drug: Omni-stat Celox

Interventions

Omni-stat CeloxDRUG

Topical administration of 6 gr of Omnistat Celox

Omni-stat Celox
ControlDRUG

Traditional surgical Hemostasis

Control

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients undergoing heart surgery

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

European Hospital

Rome, 00152, Italy

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project Leader Luca Weltert

Study Record Dates

First Submitted

November 3, 2009

First Posted

November 5, 2009

Study Start

January 1, 2010

Primary Completion

August 1, 2010

Study Completion

September 1, 2010

Last Updated

February 22, 2012

Record last verified: 2012-02

Locations

IT(1)