NCT02812355

Brief Summary

The RATIO Study is a multicenter, nationwide, randomized, controlled, single blinded, unfunded trial of n. 900 patients undergoing multivessel OPCAB (≥2 grafts). This study is designed to test in patients undergoing off-pump coronary artery bypass surgery the hypothesis that full (high dose, 300 U/kg) and half (low dose,150 U/kg) heparinization are not different in terms of thrombotic complications and major perioperative bleeding events (null hypothesis).

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
900

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2017

Typical duration for phase_4

Geographic Reach
2 countries

3 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

June 22, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 24, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

May 12, 2017

Status Verified

May 1, 2017

Enrollment Period

2 years

First QC Date

June 22, 2016

Last Update Submit

May 11, 2017

Conditions

Ischemic Heart Disease

Keywords

off-pumpcoronary artery bypassheparinization

Outcome Measures

Primary Outcomes (2)

  • Composite vascular

    Death from vascular causes, perioperative myocardial infarction, stroke.

    30 days post-operatively

  • Composite major bleeding

    Redo for excessive bleeding, cardiac tamponade, transfusion ≥3 Units of packed red cells or of platelets.

    48 hours post-operatively

Secondary Outcomes (6)

  • Post-operative bleeding

    48 hours post-operatively

  • Transfusion of packed red cells (<3 Units) or of platelets

    30 days post-operatively

  • Peak value of cardiac biomarker

    30 days post-operatively

  • Transient ischemic cerebral attack

    30 days post-operatively

  • Mesenteric ischemia (angiography or CT scan)

    30 days post-operatively

  • +1 more secondary outcomes

Study Arms (2)

half heparinization

EXPERIMENTAL

heparin I.V. 150 U/kg

Drug: Heparin

full heparinization (300 U/kg)

ACTIVE COMPARATOR

heparin I.V. 300 U/kg

Drug: Heparin

Interventions

HeparinDRUG
full heparinization (300 U/kg)half heparinization

Eligibility Criteria

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

You may qualify if:

  • Consecutive patients electively undergoing multivessel OPCAB

You may not qualify if:

  • Acute coronary syndrome, on-going double anti-platelets treatment (the second antiplatelet drug should be suspended 5 days before surgery), on-going intravenous heparin or sub-cutaneous low molecular weight heparin, known coagulopathy, documented liver disease, chronic renal failure (creatinine ≥ 2 mg/dl) or previous renal transplantation surgery, previous cardiac surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Jilin Heart Hospital

Changchun, Jilin, China

RECRUITING

ASST Lecco

Lecco, 23900, Italy

RECRUITING

Azienda Ospedaliera Universitaria di Sassari

Sassari, Italy

RECRUITING

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Heparin

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Michele NR Triggiani, MD, PhD

    ASST Lecco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michele NR Triggiani, MD, PhD

CONTACT

+39-0341253066m.triggiani@asst-lecco.it

Antonello S Martino, MD

CONTACT

+39-0341253651as.martino@asst-lecco.it

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

June 22, 2016

First Posted

June 24, 2016

Study Start

January 1, 2017

Primary Completion

January 1, 2019

Study Completion

February 1, 2019

Last Updated

May 12, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)IT(2)