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Comparison of Two Dosages of Heparin Before Extracorporeal Circulation

Comparison of Two Dosages of Heparin Before Extracorporeal Circulation

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03752437
Enrollment
150
Registered
2018-11-26
Start date
2019-10-01
Completion date
2021-09-30
Last updated
2022-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extracorporeal Circulation; Complications

Brief summary

In this study the investigators will study two dosages of heparin before extracorporeal circulation in open chest cardiac surgery.

Detailed description

In this study the investigators will study two dosages of heparin before extracorporeal circulation in open chest cardiac surgery. The first dosage will be 300 IU per kilogram of REAL weight, the second dosage will be 300 IU per kilogram of IDEAL weight.

Interventions

DIAGNOSTIC_TESTACT (Activated Clotting Time)

Measure of ACT in the two arms in order to determine if injection of heparin based on ideal weight is better or not than those one on real weight.

DRUGHeparin

300 IU of heparin

Sponsors

Astes
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)

Masking description

Randomisation by computer, different sheet for encoding data.

Intervention model description

One arm will receive 300 IU of heparin based on real weight, and the other arm will receive 300 IU of heparin based on ideal weight.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All patients admitted for cardiac open chest surgery

Exclusion criteria

* Patient's refusal * Antithrombin III factor \< 75% * Patient under treatment by heparin IV

Design outcomes

Primary

MeasureTime frameDescription
ACT performance1 minuteMeasure of ACT to be \> 400 seconds to allow extracorporeal circulation, but also \< 700 seconds to avoid excessive bleeding.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026