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Outcome Measures

Primary Outcomes (1)

Combined incidence of all thrombo-embolic complications (TEC) and all-cause mortality.
TEC are any complication as caused by thrombus or embolus perioperatively, including but not exclusively: myocardial infarction, leg ischemia, deep venous thrombosis, colon ischemia, transient ischemic attack (TIA)/stroke, graft thrombosis, peroperative thrombus requiring embolectomy or redo of an anastomosis, thrombus or embolus in organs or lower limbs and other peripheral thrombosis. Incidence of bleeding complications according to European multicenter study on Coronary Artery Bypass Grafting (E-CABG) classification, grade 1 and higher: per- or postoperative transfusion of 2 or more units of red blood cells, transfusion of platelets, transfusion of fresh frozen plasma or reoperation for bleeding during hospital stay.
Within 30 days or during the same admission in hospital

Secondary Outcomes (1)

Complications (non-TEC).
Within 30 days or during the same admission in hospital

Study Arms (2)

ACT guided heparinization

EXPERIMENTAL

Heparin is given to reach an ACT of 200-220 seconds. At the start of the procedure, before any heparin is given, a baseline ACT measurement is performed. 3-5 minutes before clamping of the aorta 100 IU/kg bodyweight of heparin is administrated intravenously. 5 minutes after administration of heparin, ACT measurement is performed.

Drug: ACT guided heparinization

5 000 IU of heparin

ACTIVE COMPARATOR

A single dose of 5 000 IU of heparin is given 3-5 minutes before clamping of the aorta. No ACT measurements are performed, except for one ACT measurement after re-establishing blood flow and removing all clamps. Depending on that ACT value near the end of surgery, the local protamine can be given to neutralize the effect of heparin. Only on clarified indications extra doses of heparin or protamine are permitted, at the discretion of the attending vascular surgeon. Indications could be clot formation intravascular or in a prosthesis, excessive bleeding or prolonged operation duration. Deviations from protocol should be clearly stated with reasoning in the operative report.

Drug: 5 000 IU of heparin

Interventions

ACT guided heparinizationDrug

If the ACT is \<180 sec., an additional dose of heparin of 60 IU/kg is administered. If the ACT is 180-200 sec., 30 IU/kg. If the ACT is \>200 sec., no extra heparin is given. 5 min. after every administration of heparin the ACT is measured. If the ACT is \>200 sec, the next ACT measurement is performed every 30 min., until the end of the procedure or until new heparin administration is required. After each new dose of heparin, an ACT measurement is performed after 5 min. and the above- described protocol of ACT measurements will be repeated. After re-establishing blood flow and removing all clamps, the ACT is measured. If the ACT at closure is 200-250 sec., 2500 IU of protamine should be administered. If \>250 sec., 5000 IU protamine. If 180-200 sec., 1000 IU protamine. 5 min. after the administration of protamine, the ACT is measured. The ACT should preferably be below 180 sec. If the ACT is still more than 200 sec., protamine should be administered again.

ACT guided heparinization

5 000 IU of heparin

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Able to speak and read in local language of trial hospital.
Patients older than 18 years scheduled for elective, open repair of an iliac or abdominal aortic aneurysm distal of the Superior Mesenteric Artery (SMA) (DSAA segment C).

Study Sites (22)

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Krankenhaus Barmherzige Brüder

Regensburg, Germany

Treant Zorggroep

Emmen, Drenthe, 7824AA, Netherlands

Gelre Ziekenhuizen

Apeldoorn, Gelderland, 7334DZ, Netherlands

Rijnstate

Arnhem, Gelderland, 6815 AD, Netherlands

Slingeland Ziekenhuis

Doetinchem, Gelderland, 7009BL, Netherlands

Elisabeth TweeSteden Ziekenhuis

Tilburg, Noord-Braband, 5022 GC, Netherlands

Related Publications (33)

Burgers LT, Vahl AC, Severens JL, Wiersema AM, Cuypers PW, Verhagen HJ, Redekop WK. Cost-effectiveness of Elective Endovascular Aneurysm Repair Versus Open Surgical Repair of Abdominal Aortic Aneurysms. Eur J Vasc Endovasc Surg. 2016 Jul;52(1):29-40. doi: 10.1016/j.ejvs.2016.03.001. Epub 2016 Apr 23.

PMID: 27118618BACKGROUND

Behrendt CA, Sedrakyan A, Riess HC, Heidemann F, Kolbel T, Petersen J, Debus ES. Short-term and long-term results of endovascular and open repair of abdominal aortic aneurysms in Germany. J Vasc Surg. 2017 Dec;66(6):1704-1711.e3. doi: 10.1016/j.jvs.2017.04.040. Epub 2017 Aug 7.

PMID: 28780975BACKGROUND

Study Design

Study Type

interventional

Phase

phase 4

Allocation

RANDOMIZED

Masking

SINGLE

Who Masked

PARTICIPANT

Masking Details

Patients will be randomized using a computerized program (CASTOR EDC) with a random block size of a maximum of 8. The randomization will be stratified by participating centre. The participant is blinded to the allocated treatment. Separate evaluation of results and if complications can be labelled as TEC, will be performed by an Independent Central Adjudication Committee. The 3 members of this Committee will be blinded to the allocated treatment. Since the care provider and investigator have to do the ACT measuring, it is impossible to blind them to the allocated treatment.

Purpose

TREATMENT

Intervention Model

PARALLEL

Model Details: Intervention group: Heparin is given to reach an ACT of 200-220 seconds. At the start of the procedure, before any heparin is given, a baseline ACT measurement is performed. 3-5 minutes before clamping of the aorta 100 IU/kg bodyweight of heparin is administrated intravenously. 5 minutes after administration of heparin, ACT measurement is performed. Comparative group: A single dose of 5 000 IU of heparin is given 3-5 minutes before clamping of the aorta. No ACT measurements are performed, except for one ACT measurement after re-establishing blood flow and removing all clamps.

Sponsor Type

OTHER

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

MD, PhD, Vascular Surgeon

Study Stopped

ACT Guided Heparinization During Open Abdominal Aortic Aneurysm Repair.

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

ACT guided heparinization

5 000 IU of heparin

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (22)

Related Publications (33)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

ACT guided heparinization

5 000 IU of heparin

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (22)

Related Publications (33)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations