NCT00657475

Brief Summary

The purpose of this study is to demonstrate superiority on postoperative bleeding from the use of a heparin half dose compared to a conventional dose, under mini-extra corporeal circulation, without increased risk to the patient.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
238

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2008

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

April 8, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 14, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

May 7, 2013

Status Verified

May 1, 2013

Enrollment Period

4.7 years

First QC Date

April 8, 2008

Last Update Submit

May 6, 2013

Conditions

Cardiac SurgeryExtracorporeal Circulation

Keywords

Heparin low doseInflammationBlood loss

Outcome Measures

Primary Outcomes (1)

  • Blood loss

    Peroperative and postoperative until redon's suction drainage ablation

Secondary Outcomes (4)

  • Blood transfusion

    Per & postoperative

  • Use of intropic drugs (posology)

    Postoperative

  • Kidney function(urea, creatininemia)

    Postoperative

  • Peroperative hemodynamic data

    Peroperative

Study Arms (2)

2

EXPERIMENTAL

Cardiac surgery with Mini Extra Corporeal Circulation (MECC). Heparin low dose (150 UI/Kg).

Drug: Heparin Low Dose

1

ACTIVE COMPARATOR

Cardiac surgery with Mini Extra Corporeal Circulation (MECC). Heparin Full Dose (300 UI/Kg)

Drug: Heparin Full Dose

Interventions

Heparin Low DoseDRUG

Loading heparin dose of 150 IU / kg to achieve an ACT (activating clotting time) target more than 240 seconds.

2
Heparin Full DoseDRUG

Loading heparin dose of 300 IU / kg to achieve an ACT (activating clotting time) target more than 400 seconds.

1

Eligibility Criteria

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

You may qualify if:

  • single or multiple coronary bypass
  • written and informed consent
  • repair or replacement of artic leaflet
  • platelet suppressive agents stopped since at least 7 days
  • anticoagulants stopped since at least 3 days

You may not qualify if:

  • Thoracic surgery antecedent
  • ASA 4
  • carotid stenosis \> 75%
  • Hb \< 10,5 g/l
  • chronic hepatic failure
  • thromboembolic antecedent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiac Surgery Dpt (University Hospital)

Bordeaux, 33000, France

Location

MeSH Terms

Conditions

InflammationHemorrhage

Interventions

Heparin

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Xavier ROQUES, PhD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2008

First Posted

April 14, 2008

Study Start

June 1, 2008

Primary Completion

February 1, 2013

Study Completion

March 1, 2013

Last Updated

May 7, 2013

Record last verified: 2013-05

Locations

FR(1)