Extracorporeal Membrane Oxygenation ComplicationNCT06275555
Use of Bivalirudin for Anticoagulation in Patients With Extracorporeal Membrane Oxygenation
A study testing bivalirudin and unfractionated heparin in people with Extracorporeal Membrane Oxygenation Complication, run by Xiaotong Hou at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extracorporeal Membrane Oxygenation Complication
- What is being tested?
- bivalirudin and unfractionated heparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteChina
- Study dates
- 3 Jun 2024to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- have participated in this study before.
- the researchers believe that there are other factors that are not suitable to participate in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100029
Liangshan Wang, MD, 86-13811363372, wangliangshanbam@sina.com
About this study
Official title: Efficacy and Safety of Bivalirudin Versus Heparin in Anticoagulant Therapy of ECMO: a Randomized Controlled 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.
Read the detailed description
Patients with ECMO who needed systemic anticoagulation were randomly divided into bivalirudin group and unfractionated heparin group;the efficacy of bivalirudin in ECMO anticoagulation was evaluated by comparing the percentage of time within the target anticoagulation level and the incidence of thrombotic complications between the two groups during ECMO; and the safety of bivalirudin in ECMO anticoagulation was evaluated by comparing bleeding complications, blood product infusion and the incidence of acute renal failure between the two groups.
- Being tested
- bivalirudin, unfractionated heparin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bivalirudinDrug
bivalirudin as an anticoagulant
unfractionated heparinDrug
unfractionated heparin as an anticoagulant
| Study group | Role | What they receive |
|---|---|---|
| bivalirudin group | Experimental | If the creatinine clearance rate > 30ml/min, the initial dose of bivalirudin is 0.04mg/kg/h. If the creatinine clearance rate<30ml/min or the patients who have received renal replacement therapy (CRRT), the initial dose of bivalirudin is 0.02mg/kg/h, and the dose is adjusted according to APPT to maintain APTT at 40-60s. After bivalirudin started, APTT was checked every 4 hours. If APTT was in the target range twice in a row, it was re-examined every 12 hours. Receives: Drug: bivalirudin |
| unfractionated heparin group | Other | The initial dose of heparin was 8-12U/kg/h, and the dosage of heparin was adjusted according to the value of APTT. APTT was maintained at 40-60s, and APTT was reexamined every 4 hours. Receives: Drug: unfractionated heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
thrombotic complications
main end point of efficacy
Measured: Within seven days after starting anticoagulant therapy
bleeding complications
main safety endpoint
Measured: Within seven days after starting anticoagulant therapy
Secondary outcomes (7)
Hospitalization mortality
All-cause death
Measured: 28 days
Loop replacement
Measured: Within seven days after starting anticoagulant therapy
Infusion volume of blood products
Plasma, platelets and red blood cells
Measured: Within seven days after starting anticoagulant therapy
Acute renal failure
Incidence rate
Measured: Within seven days after starting anticoagulant therapy
Heparin-induced thrombocytopenia
Incidence rate
Measured: Within seven days after starting anticoagulant therapy
the time of reaching the target anticoagulant level for the first time
Measured: Within seven days after starting anticoagulant therapy
Percentage of time during ECMO within the target anticoagulant level
APTT maintained at 40-60s
Measured: Within seven days after starting anticoagulant therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start3 Jun 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extracorporeal Membrane Oxygenation ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiaotong Hou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaotong Hou, Beijing Anzhen Hospital
- Investigators
- Liangshan Wang, MD, Study chair, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06275555
- Sponsor's protocol ID
- 2023-101
- Status last verified
- Apr 2026
- First submitted
- 17 Feb 2024
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Bivalirudin Versus Heparin in Anticoagulant Therapy of ECMO: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06275555
- Acronym / sponsor ID
- 2023-101
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Xiaotong HouUniversity, hospital or other
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients with ECMO who needed systemic anticoagulation were randomly divided into bivalirudin group and unfractionated heparin group;the efficacy of bivalirudin in ECMO anticoagulation was evaluated by comparing the percentage of time within the target anticoagulation level and the incidence of thrombotic complications between the two groups during ECMO; and the safety of bivalirudin in ECMO anticoagulation was evaluated by comparing bleeding complications, blood product infusion and the incidence of acute renal failure between the two groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bivalirudin group | Experimental | Drug: bivalirudinIf the creatinine clearance rate > 30ml/min, the initial dose of bivalirudin is 0.04mg/kg/h. If the creatinine clearance rate<30ml/min or the patients who have received renal replacement therapy (CRRT), the initial dose of bivalirudin is 0.02mg/kg/h, and the dose is adjusted according to APPT to maintain APTT at 40-60s. After bivalirudin started, APTT was checked every 4 hours. If APTT was in the target range twice in a row, it was re-examined every 12 hours. |
| unfractionated heparin group | Other | Drug: unfractionated heparinThe initial dose of heparin was 8-12U/kg/h, and the dosage of heparin was adjusted according to the value of APTT. APTT was maintained at 40-60s, and APTT was reexamined every 4 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
- have participated in this study before.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bivalirudinbivalirudin as an anticoagulant | Drug | bivalirudin group |
| unfractionated heparinunfractionated heparin as an anticoagulant | Drug | unfractionated heparin group |
Primary outcome
thrombotic complications
Time frame: Within seven days after starting anticoagulant therapy
main end point of efficacy
bleeding complications
Time frame: Within seven days after starting anticoagulant therapy
main safety endpoint
7 secondary outcomes
Hospitalization mortality
Time frame: 28 days
Loop replacement
Time frame: Within seven days after starting anticoagulant therapy
Infusion volume of blood products
Time frame: Within seven days after starting anticoagulant therapy
Acute renal failure
Time frame: Within seven days after starting anticoagulant therapy
Heparin-induced thrombocytopenia
Time frame: Within seven days after starting anticoagulant therapy
the time of reaching the target anticoagulant level for the first time
Time frame: Within seven days after starting anticoagulant therapy
Percentage of time during ECMO within the target anticoagulant level
Time frame: Within seven days after starting anticoagulant therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Liangshan Wang, MD study chair
Beijing Anzhen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bivalirudin and unfractionated heparin in people with Extracorporeal Membrane Oxygenation Complication, run by Xiaotong Hou at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaotong Hou, MD (010-64456631, xt.hou@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
thrombotic complications (time frame: Within seven days after starting anticoagulant therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.