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Trial record 8 of 81550 for:    measured

Measuring the ACT During Non-cardiac Arterial Procedures. (MANCO)

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ClinicalTrials.gov Identifier: NCT03426293
Recruitment Status : Recruiting
First Posted : February 8, 2018
Last Update Posted : February 8, 2018
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Arno Wiersema, Dijklander Ziekenhuis

Tracking Information
First Submitted Date January 27, 2018
First Posted Date February 8, 2018
Last Update Posted Date February 8, 2018
Actual Study Start Date December 21, 2016
Estimated Primary Completion Date December 21, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 1, 2018)
Change of Activated Clotting Time [ Time Frame: ACT measured before heparin, 5 minutes after and than at 30 minutes intervals. After a repeated dose of heparin again after 5 minutes and 30 minutes intervals ]
Change of Activated Clotting Time, before and after administration of heparin
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: February 1, 2018)
Complications [ Time Frame: 30 days or same admission, 6 weeks, 6 months and 12 months ]
All complications as depicted in Suggested Standards for reports on arterial procedures and local complication registration. Vascular and non-vascular
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Measuring the ACT During Non-cardiac Arterial Procedures.
Official Title MANCO: Measuring the ACT During Non-cardiac Arterial Procedures.
Brief Summary Aim of the MANCO study is to establish for once and for all that monitoring the effect of heparin during NCVI (Non-Cardiac Vascular Interventions) is essential to ensure the individual patient of safe and tailor-made anticoagulation. Not measuring the effect of the administered heparin exposes the patient to unnecessary risks of thrombo-embolic and bleeding complications. First aim of the MANCO study is to prove that the standardized bolus of 5000 IU of heparin, used by 90% of vascular specialists in Europe, results in inadequate anticoagulation in more than 80% of patients. These measurements will be performed using the Hemostasis Management System by Medtronic.
Detailed Description

Heparin is used worldwide by all vascular surgeons and interventional radiologists (IR) during non-cardiac vascular interventions (NCVI), both open and endovascular. Heparin is used to reduce or prevent arterial thrombo-embolic complications (ATEC). Heparin reduces the clotting of blood and thereby coagulation. This also explains the negative side-effect of using heparin: its use can lead to bleeding-complications, possibly causing the need for blood tranfusions, more hematomas necessitating re-interventions and increasing the risk of infections.

Since the 1970's it is well known that heparin has a non-linear dose response curve and also a non-linear elimination curve in the individual patient.

Despite this fact, more than 95% of all vascular surgeons and IR use a standardized bolus of 5000 IU in every patient. Multiple studies have demonstrated that up to 70% of patients is not adequately anticoagulated during NCVI using that bolus of 5000 IU.

During open or endovascular cardiac interventions the effect of heparin is always routinely measured using the activated clotting time (ACT).

Despite this knowledge the percentage of vascular surgeons and/or IR that measure the effect of heparin during NCVI routinely is astonishing low: 0-5%, in the US this percentage is probably higher (30%), possibly due to medico-legal reasons. Existing guidelines on NCVI depict different regimes on the use of heparin or do not mention this use at all.

The Hemostasis Management System (HMS, Medtronic) measures the ACT, but it also calculates a heparin dose response curve in the individual patient. This curve supplies the vascular surgeon or IR a tool to administer the exact amount of heparin needed to reach a desired ACT. Also the exact dose of protamine can be calculated to neutralize the effect of remaining circulating heparin in the individual patient. The use of the HMS in cardiac vascular procedures has to led to a reduced need for blood transfusions, less postoperative bleeding complications and a reduction of peri-procedural myocardial infarctions and other ATEC.

To determine if the HMS can be of equal high value during NCVI, a pilot study was performed at the VUMC, called Hepvasc. Results of this pilot (submitted) and other sparse results from literature, show that HMS can be used during NCVI. Furthermore, results indicated that the bolus of 5000 IU resulted in inadequate anticoagulation in 7 out of 18 included patients. This exposes those patients to a higher risk of ATEC.

As a result of this pilot, the MANCO study is designed with the HMS during NCVI. The MANCO study will evaluate the data of heparin management with the HMS in number of large vascular centers, starting in the Netherlands and after that in Europe. Measurements with the HMS will be used for the evaluation of the local heparin protocol by the individual vascular surgeon or IR. The MANCO study will be started permitting every center to apply their current heparin protocol. This includes the dosage of heparin and possible extra dosing of heparin to reach a desired ACT. The MANCO study is started as a prospective data registry and observational study of the ACT with an extensive case record form (CRF). Regular blood samples for ACT measurements will be done, so no extra invasive measurements are performed in the patient. Data will be collected according to all legal requirements and permission of local medical ethics committees is granted.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 12 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population - All patients in participating centers undergoing NCVI, older than 18 years
Condition
  • Arterial Disease
  • Surgery
  • PTA
  • Peripheral Arterial Disease
Intervention Other: Measuring the ACT to determine effect of heparin
Measuring the ACT to determine effect of heparin during non-cardiac arterial procedures
Study Groups/Cohorts Arterial procedure and ACT measurement
All patients undergoing an open or endovascular arterial procedure in which heparin is used peri-procedurally and the ACT is measured to determine effect of heparin
Intervention: Other: Measuring the ACT to determine effect of heparin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 1, 2018)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 21, 2019
Estimated Primary Completion Date December 21, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All patients in participating centers undergoing Non-Cardiac Vascular (arterial) Intervention open or endovascular, older than 18 years

Exclusion Criteria:

  • Patients with a known history of coagulation disorders or a EGFR lower than 30 ml/min.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Arno M Wiersema, MD, PhD 0031653444515 arno@wiersema.nu
Contact: Vincent Jongkind, MD, PhD 0031229257257 v_jongkind@yahoo.com
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT03426293
Other Study ID Numbers M016-045
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: All ACT values can be obtained after trial with PI
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: after completion
Access Criteria: mail PI
Responsible Party Arno Wiersema, Dijklander Ziekenhuis
Study Sponsor Dijklander Ziekenhuis
Collaborators Medtronic
Investigators
Principal Investigator: Arno M Wiersema, MD, PhD Dijklander Ziekenhuis
PRS Account Dijklander Ziekenhuis
Verification Date February 2018