Measuring the ACT During Non-cardiac Arterial Procedures. (MANCO)
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| ClinicalTrials.gov Identifier: NCT03426293 |
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Recruitment Status :
Recruiting
First Posted : February 8, 2018
Last Update Posted : February 8, 2018
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| Condition or disease | Intervention/treatment |
|---|---|
| Arterial Disease Surgery PTA Peripheral Arterial Disease | Other: Measuring the ACT to determine effect of heparin |
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] |
| 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 |
| Group/Cohort | Intervention/treatment |
|---|---|
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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
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Other: Measuring the ACT to determine effect of heparin
Measuring the ACT to determine effect of heparin during non-cardiac arterial procedures |
- 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
- 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 |
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.
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
| Contact: Arno M Wiersema, MD, PhD | 0031653444515 | arno@wiersema.nu | |
| Contact: Vincent Jongkind, MD, PhD | 0031229257257 | v_jongkind@yahoo.com |
| 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 | |
| Principal Investigator: | Arno M Wiersema, MD, PhD | Dijklander Ziekenhuis |
Additional Information:
Publications:
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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heparin;ACT;non-cardiac vascular;peri-procedural |
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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 |