Coagulation in Acute Aortic Dissection

NACompletedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

November 1, 2022

Primary Completion Date

September 17, 2024

Study Completion Date

December 15, 2024

Conditions
Acute Aortic DissectionCoagulation Disorder
Interventions
PROCEDURE

Individualized HDR-approach

"Heparin concentration necessary to achieve target ACT \> 480 sec. calculated based on individual HDR-curve.~If HDR slope ˂80 s/IU/mL (reduced sensitivity to heparin), 1000 IU of AT concentrate (Antitrombin III Baxalta®, Takeda Pharma, Vallensbæk Strand, DK). Whole blood concentration of circulating heparin assessed by heparin assays. Additional heparin given as required. After weaning, protamine necessary to reverse circulating heparin calculated according to heparin-protamine titration measurement. After protamine, heparin reversal evaluated with low-range heparin-protamine titration cartridge and additional protamine given as required."

PROCEDURE

Conventional ACT-approach

"Initial Heparin 400 IU/kg (500 IU/kg if treated with heparin prior to surgery). ACT Assessment with Hemochron® Signature Elite (ITC, International Technidyne Corp., Edison, NJ, USA).~Additional heparin until ACT \> 480 sec. If ACT \< 480 sec. after despite repeated heparin supplement with 1000 IU of AT III concentrate. Target ACT \> 480 sec. during normothermic CPB, and target ACT \> 700 seconds during hypothermia After weaning, protamine 10mg/mL (0.7 mg of protamine/ 100 IU total heparin administered). Heparin reversal is evaluated with an activated partial thromboplastin (APTT). If APTT \> 40 seconds, additional protamine (25-50 mg i.v.)."

Trial Locations (1)

8200

Aarhus University Hospital Skejby, Aarhus

All Listed Sponsors
lead

Ivy susanne Modrau, MD

OTHER