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Use of Bivalirudin for Anticoagulation in Patients With Extracorporeal Membrane Oxygenation

ConditionExtracorporeal Membrane Oxygenation Complication
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorXiaotong Hou

About this trial

The purpose of this study was to evaluate the efficacy and safety of bivalirudin in anticoagulation therapy in patients with extracorporeal membrane oxygenation (ECMO) compared with unfractionated heparin.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years old

Accept VA-ECMO or VV-ECMO

the ECMO team believes that systemic anticoagulation is necessary and that APTT should be maintained at 40-60s.

sign the informed consent form

Disqualifiers

previous history of allergy to heparin or bivalirudin

previous diagnosis of heparin-induced thrombocytopenia.

the pre-random ECMO assistance time is more than 48 hours.

pregnant female

Trial design

Design model

Parallel

Treatments tested in this trial

  • bivalirudin

    Drug

    bivalirudin as an anticoagulant

  • unfractionated heparin

    Drug

    unfractionated heparin as an anticoagulant

Treatment groups

154 Participants
are divided into 2 treatment groups
Group A: bivalirudin groupExperimental treatment 1 intervention
Group B: unfractionated heparin groupOther 1 intervention

Trial outcomes

Primary outcomes

1

thrombotic complications

main end point of efficacy

Time frame
Within seven days after starting anticoagulant therapy
2

bleeding complications

main safety endpoint

Time frame
Within seven days after starting anticoagulant therapy

Secondary outcomes

1

Hospitalization mortality

All-cause death

Time frame
28 days
2

Loop replacement

Time frame
Within seven days after starting anticoagulant therapy
3

Infusion volume of blood products

Plasma, platelets and red blood cells

Time frame
Within seven days after starting anticoagulant therapy
4

Acute renal failure

Incidence rate

Time frame
Within seven days after starting anticoagulant therapy

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xiaotong Hou

Lead sponsor

Beijing Anzhen Hospital

Sponsor institution

Source ClinicalTrials.gov
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