Anticoagulation bridging: the substitution of sintrom by heparin in the periprocedural period: the Brug study

Anticoagulation bridging: the substitution of sintrom by heparin in the periprocedural period: the Brug study - the Brug study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON37436

Enrollment

Registered

2013-01-16

Start date

2013-06-04

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

bloedingen thromboembolism

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Chronic, more than 3 months VKA use Acenocoumarol use An invasive procedure is planned (scopy or small intervention) The patient is bridged with heparin

Exclusion criteria

Exclusion criteria: Renal failure (MDRD clearance

Design outcomes

Primary

Measure	Time frame
Primary: The perioperative measurement of various plasma proteins as well as the SNPs VKORC1 and CYP2C9 combined with the values of aPTT / INR and anti-FXa allows us to test the validity of our model for use in clinical practice. We want to have both the aPTT / anti-FXa and the INRs, measured once daily, from 3 days before surgery to 5 days after surgery. If aPTT / anti-FXa and INR of the patient are within the therapeutic framework during the study period, there is a good balance between bleeding risk and risk of thrombosis. We have the following reference values for the morning before the surgery: INR	—

Measure

Time frame

Primary: The perioperative measurement of various plasma proteins as well as the SNPs VKORC1 and CYP2C9 combined with the values of aPTT / INR and anti-FXa allows us to test the validity of our model for use in clinical practice. We want to have both the aPTT / anti-FXa and the INRs, measured once daily, from 3 days before surgery to 5 days after surgery. If aPTT / anti-FXa and INR of the patient are within the therapeutic framework during the study period, there is a good balance between bleeding risk and risk of thrombosis. We have the following reference values for the morning before the surgery: INR

—

Secondary

Measure	Time frame
Secondary: The data obtained from the patients can be used for further quantitative improvement of the model. The 30 days perioperative monitoring of the participants gives us an idea of the expected rate of bleeding and thromboembolic events during the bridging period in the MUMC + and will help us to determine the sample size of a possible future study.	—

Countries

Netherlands

Outcome results