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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

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.

Condition or disease Intervention/treatment
Arterial Disease Surgery PTA Peripheral Arterial Disease Other: Measuring the ACT to determine effect of heparin

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: MANCO: Measuring the ACT During Non-cardiac Arterial Procedures.
Actual Study Start Date : December 21, 2016
Estimated Primary Completion Date : December 21, 2019
Estimated Study Completion Date : December 21, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Group/Cohort Intervention/treatment
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
Other: Measuring the ACT to determine effect of heparin
Measuring the ACT to determine effect of heparin during non-cardiac arterial procedures




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
- All patients in participating centers undergoing NCVI, older than 18 years
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03426293


Contacts
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Contact: Arno M Wiersema, MD, PhD 0031653444515 arno@wiersema.nu
Contact: Vincent Jongkind, MD, PhD 0031229257257 v_jongkind@yahoo.com

Locations
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Netherlands
Vrije Universiteit Medisch Centrum Recruiting
Amsterdam, Noord-Holland, Netherlands, 1081HV
Contact: Kakkhee Yeung, MD, PhD    0031204444444    kakkhee.yeung@gmail.com   
Westfriesgasthuis Recruiting
Hoorn, Noord-Holland, Netherlands, 1624NP
Contact: Arno M Wiersema, MD, Phd    0031229208206    a.wiersema@westfriesgasthuis.nl   
Contact: Vincent Jongkind, MD, PhD    0031229257257    v_jongkind@yahoo.com   
Isala klinieken Recruiting
Zwolle, Netherlands, 8025 AB
Contact: Maurice Pierie, Md, PhD    0031384245000    maurice_pierie@hotmail.com   
Sponsors and Collaborators
Dijklander Ziekenhuis
Medtronic
Investigators
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Principal Investigator: Arno M Wiersema, MD, PhD Dijklander Ziekenhuis

Additional Information:

Publications:

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Responsible Party: Arno Wiersema, Principal Investigator, Dijklander Ziekenhuis
ClinicalTrials.gov Identifier: NCT03426293     History of Changes
Other Study ID Numbers: M016-045
First Posted: February 8, 2018    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All ACT values can be obtained after trial with PI
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: after completion
Access Criteria: mail PI

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arno Wiersema, Dijklander Ziekenhuis:
heparin;ACT;non-cardiac vascular;peri-procedural
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Heparin
Calcium heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action