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

Recruiting

Conditions: bloedingen
thromboembolism
blood cloth
10014523

Registration Number: NL-OMON37436

Lead Sponsor: Philips Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 36

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

Renal failure (MDRD clearance < 30 ml/min/1.73m2)
Heparin induced thrombocytopenia (HIT)
Documented contra indication for heparin
Emergency procedures

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary: The perioperative measurement of various plasma proteins as well as<br /><br>the SNPs VKORC1 and CYP2C9 combined with the values of aPTT / INR and anti-FXa<br /><br>allows us to test the validity of our model for use in clinical practice. We<br /><br>want to have both the aPTT / anti-FXa and the INRs, measured once daily, from 3<br /><br>days before surgery to 5 days after surgery. If aPTT / anti-FXa and INR of the<br /><br>patient are within the therapeutic framework during the study period, there is<br /><br>a good balance between bleeding risk and risk of thrombosis. We have the<br /><br>following reference values for the morning before the surgery: INR <1.5, aPTT<br /><br>23-32 seconds.</p><br>

Secondary Outcome Measures

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