A prospective randomized pilot trial on safety and feasibility of Argatroban as blood thinner in patients with heart-lung machine

A prospective randomized pilot trial on safety and feasibility of Argatroban as anticoagulant in patients with extracorporeal membrane oxygenation (ECMO)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-001456-34-AT

Enrollment

Registered

2021-05-25

Start date

2021-07-08

Completion date

Unknown

Last updated

2026-03-16

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

Conditions

patients requiring treatment with extracorporeal membrane oxygenation

Interventions

Pharmaceutical Form: Solution for infusion INN or Proposed INN: ARGATROBAN CAS Number: 74863-84-6 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Minimum Age 18 years • VV- or VA-ECMO therapy • Minimum of 24h planned ECMO-therapy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: • History of Heparin-induced thrombocytopenia (HIT) • High risk of bleeding, contraindication for anticoagulation (eg. active GI-bleeding, Intracerebral bleeding; Platelet count 12mg/dl) • Postoperative admission • Strong lupus anticoagulant or acquired intrinsic clotting factor deficiency at admission (APTT >50 sec without anticoagulation).

Design outcomes

Primary

Measure	Time frame
Main Objective: •Safety of Argatroban as anticoagulant in ECMO ;Secondary Objective: •Feasibility of Argatroban as anticoagulant in ECMO (study enrollment, study completion and ability to achieve target values (proportion of coagulation tests within range) •Quantification of bleeding events through need of PRBCs (packed red blood cells during ECMO, average/d; transfusion threshold: Hb<8g/dl) •Grading of bleeding •Venous thrombosis after canula removal (sonsography 24h after canula removal) •Number of patients switched to argatroban (confirmed HIT) •Coagulation studies: oGlobal clotting tests (aPTT, ACT, PTZ, Thrombin Time (TT), Fibrinogen, D-Dimer) oPlatelet-factor-4 (PF4) antibodies oSpecific coagulation tests oUFH: AntiXa oArgatroban: Hemoclot Assay, Thrombelastometry (ClotPro) ;Primary end point(s): •Safety of Argatroban as anticoagulant in ECMO Assessed by a combined endpoint of bleeding and thrombosis compared to patients receiving unfractionated Heparin (UFH) ;Timepoint(s) of evaluation of this end point: End of ECMO treatment	—

Measure

Time frame

Main Objective: •Safety of Argatroban as anticoagulant in ECMO ;Secondary Objective: •Feasibility of Argatroban as anticoagulant in ECMO (study enrollment, study completion and ability to achieve target values (proportion of coagulation tests within range) •Quantification of bleeding events through need of PRBCs (packed red blood cells during ECMO, average/d; transfusion threshold: Hb<8g/dl) •Grading of bleeding •Venous thrombosis after canula removal (sonsography 24h after canula removal) •Number of patients switched to argatroban (confirmed HIT) •Coagulation studies: oGlobal clotting tests (aPTT, ACT, PTZ, Thrombin Time (TT), Fibrinogen, D-Dimer) oPlatelet-factor-4 (PF4) antibodies oSpecific coagulation tests oUFH: AntiXa oArgatroban: Hemoclot Assay, Thrombelastometry (ClotPro) ;Primary end point(s): •Safety of Argatroban as anticoagulant in ECMO Assessed by a combined endpoint of bleeding and thrombosis compared to patients receiving unfractionated Heparin (UFH) ;Timepoint(s) of evaluation of this end point: End of ECMO treatment

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Secondary

Measure	Time frame
Secondary end point(s): • Feasibility of Argatroban as anticoagulant in ECMO (study enrollment, study completion and ability to achieve target values (proportion of coagulation tests within range) • Quantification of bleeding events through need of PRBCs (packed red blood cells during ECMO, average/d; transfusion threshold: Hb<8g/dl) • Grading of bleeding • Venous thrombosis after canula removal (sonsography 24h after canula removal) • Number of patients switched to argatroban (confirmed HIT) • Coagulation studies: o Global clotting tests (aPTT, ACT, PTZ, Thrombin Time (TT), Fibrinogen, D-Dimer) o Platelet-factor-4 (PF4) antibodies o Specific coagulation tests o UFH: AntiXa o Argatroban: Hemoclot Assay, Thrombelastometry (ClotPro) ;Timepoint(s) of evaluation of this end point: End of ECMO	—

Measure

Time frame

Secondary end point(s): • Feasibility of Argatroban as anticoagulant in ECMO (study enrollment, study completion and ability to achieve target values (proportion of coagulation tests within range) • Quantification of bleeding events through need of PRBCs (packed red blood cells during ECMO, average/d; transfusion threshold: Hb<8g/dl) • Grading of bleeding • Venous thrombosis after canula removal (sonsography 24h after canula removal) • Number of patients switched to argatroban (confirmed HIT) • Coagulation studies: o Global clotting tests (aPTT, ACT, PTZ, Thrombin Time (TT), Fibrinogen, D-Dimer) o Platelet-factor-4 (PF4) antibodies o Specific coagulation tests o UFH: AntiXa o Argatroban: Hemoclot Assay, Thrombelastometry (ClotPro) ;Timepoint(s) of evaluation of this end point: End of ECMO

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Countries

Austria

Contacts

Public ContactDepartment of Medicine I, ICU 13i2

Medical University of Vienna

+4314040044570

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 20, 2026