A Novel Strategy of ECMO Management Using Nafamostat for Regional Combined With Low Intensity Systematic Anticoagulation

ConditionECMO
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Chao Yang Hospital

About this trial

ECMO is widely used in patients with refractory respiratory and/or circulatory failure.The data shows that the incidence of bleeding and thrombotic events is still above 40%,and it is closely related to the increase in mortality rate.Therefore, optimizing ECMO anticoagulation management to reduce bleeding and thrombotic events is a key scientific issue that urgently needs to be addressed.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age older than 18 years old

received VV ECMO because of severe respiratory failure

Disqualifiers

anticoagulant contraindications

cerebral infarction or suspected patients

severe hypertension

women in gestational and lactational period

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nafamostat

    Drug

    Nafamostat combined with unfractionated heparin for anticoagulation

  • Heparin

    Drug

    unfractionated heparin for anticoagulation

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: New Anticoagulation Strategy GroupExperimental treatment 1 intervention
Group B: control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

incidence of ECMO related bleeding or thrombotic events

the incidence of ECMO related bleeding or thrombotic events,such as membrane oxygenator or tube thrombotic,local blooding.

Time frame
28 days

Secondary outcomes

1

Types and specific incidence rates of ECMO-related bleeding and thrombotic events

Time frame
28 days
2

Time from ECMO initiation to bleeding and thrombotic events

Time frame
28 days
3

ECMO duration

Time frame
28 days
4

Blood product transfusion

Time frame
28 days

Other outcomes

Sponsors and contacts

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