ECLS-Therapy in HIT II patients – safety of Argatroban- vs Heparine therapy: ECMO-SAvHE - Study

ECLS-Therapy in HIT II patients – safety of Argatroban- vs Heparine therapy: ECMO-SAvHE - Study - ECMOSAvHe

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00011416

Enrollment

200

Registered

2018-01-08

Start date

2018-01-03

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

R57.0 J80

Interventions

Group 1: standard Therapy (state of the art) . Each patient starts with Heparine ACT (goal:180 -200 sec) or PTT (60-80 sec) while patient on ECLS support Group 2: Patients (started with Heparine) in

Eligibility

Sex/Gender

All

Age

18 Years to 120 Years

Inclusion criteria

Inclusion criteria: 1) all patients on veno-venous ECLS support (app. 30 % of patients) 2) all patients on veno-arterial ECLS support (app. 70 % of patients)

Exclusion criteria

Exclusion criteria: non adult patients pregnancy hepatic insufficiency CHILD B/C non-consent severe cognitive deficite foreign language / translation problem (telephone interview)

Design outcomes

Primary

Measure	Time frame
The primary endpoint of the study is the non-sublimity of Argatroban therapy for anticoagulation and bleeding complications and thromboses. Hypothesis: Heparin and Argatroban therapy does not result in a significantly different number of thrombosis + bleeding complications. Thrombus : any observed thrombus or thrombembolic event during the therapeutic course (echocardiography, caranial/thoracic/abdomonal/CT-Scans), angiographic diagnosis, neurological ischemic events, thrombembolic events, ECLS tubing /oxygenator thrombosis, CT-analysis post oxygenator change / post ECLS-support Bleeding: every bleeding complication leading to therapeutic medical intervention , re-operation, each morphological evidence of hematoma associated compartment syndrome, all bleeding associated neurological deficits, need of transfusion of red blood cells / and or thrombocytes greater than Mean + 1.5 SD.	—

Measure

Time frame

The primary endpoint of the study is the non-sublimity of Argatroban therapy for anticoagulation and bleeding complications and thromboses. Hypothesis: Heparin and Argatroban therapy does not result in a significantly different number of thrombosis + bleeding complications. Thrombus : any observed thrombus or thrombembolic event during the therapeutic course (echocardiography, caranial/thoracic/abdomonal/CT-Scans), angiographic diagnosis, neurological ischemic events, thrombembolic events, ECLS tubing /oxygenator thrombosis, CT-analysis post oxygenator change / post ECLS-support Bleeding: every bleeding complication leading to therapeutic medical intervention , re-operation, each morphological evidence of hematoma associated compartment syndrome, all bleeding associated neurological deficits, need of transfusion of red blood cells / and or thrombocytes greater than Mean + 1.5 SD.

—

Secondary

Measure	Time frame
1) Both therapies show no variances in coagulation, bleeding, embolization or controllability (combined endpoint) 2) The number and function of thrombocytes is recovered in ECLS-HIT II patients with direct thrombin inhibition (combined endpoint) 3) The therapeutic range is achieved by argatroban and heparin in a comparable time 4) The pressure ratios and gradients on the oxygenators of the ECMO are not differently influenced by heparin or thrombin inhibition (combined endpoint) 5) The pressure relationships show a correlation to morphologic thrombus volume (CT scans). 6) The mortality of the patients is not influenced by the type of anticoagulation. Times: discharge, 1 year postoperatively 7) The frequency of the filter change does not differ between the two groups when hemodialysis / haemofiltration is added to the ECLS. 8) The thrombus load of changed oxygenators is not different in the groups (CT scans, pilot examination) 9) No accumulation of multi-organ failure occurs in any of the groups.	—

Measure

Time frame

1) Both therapies show no variances in coagulation, bleeding, embolization or controllability (combined endpoint) 2) The number and function of thrombocytes is recovered in ECLS-HIT II patients with direct thrombin inhibition (combined endpoint) 3) The therapeutic range is achieved by argatroban and heparin in a comparable time 4) The pressure ratios and gradients on the oxygenators of the ECMO are not differently influenced by heparin or thrombin inhibition (combined endpoint) 5) The pressure relationships show a correlation to morphologic thrombus volume (CT scans). 6) The mortality of the patients is not influenced by the type of anticoagulation. Times: discharge, 1 year postoperatively 7) The frequency of the filter change does not differ between the two groups when hemodialysis / haemofiltration is added to the ECLS. 8) The thrombus load of changed oxygenators is not different in the groups (CT scans, pilot examination) 9) No accumulation of multi-organ failure occurs in any of the groups.

—

Countries

Germany

Contacts

Public ContactTiziana Wieth

Universitätsklinikum Gießen und Marburg

tiziana.wieth@chiru.med.uni-giessen.de004964198544314

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026