Extracorporeal Membrane OxygenationNCT05239637
When Heparin Stopped for Anticoagulation During ECMO Decannulation
A study testing Heparin stopped before ECMO decannulation and Heparin reduced after ECMO decannulation in people with Extracorporeal Membrane Oxygenation, run by Second Affiliated Hospital of Zhengzhou University at 1 site in China.
Trial summary
Heparin (regular or unfractionated heparin, not low molecular weight heparin) is given as a bolus (50-100 units per kilogram) at the time of extracorporeal membrane oxygenation(ECMO) cannulation, and by continuous infusion during ECMO. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Extracorporeal Membrane Oxygenation
- What is being tested?
- Heparin stopped before ECMO decannulation and Heparin reduced after ECMO decannulation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2022to Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ECMO therapy was instituted to support circulatory and/or respiratory failure;
- Heparin continuous infusion for anticoagulation during ECMO;
- Native cardiac and pulmonary function improve,and the trial off is successful.
- Ensure each patient provides signed and dated informed consent.
Who cannot join
- 1.History of thrombotic diseases or coagulation disorder；
- Thrombosis or bleeding events occurred prior to allocation；
- Heparin stopped prior to allocation；
- Other anticoagulants, antiplatelets, hemostatics and other drugs affected coagulation function have been used；
- The trial off has failed;
- Pregnant and lactating patients;
Show all 9Show fewer
- Patients participated in the other studies;
- Patients couldn't accept comprehensive treatment;
- Patients couldn't acquire informed consent;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
General ICU of the second affiliated hospital of zhengzhou university
Zhengzhou, Henan, 450000
Liu xiaojun, Bachelor, drliuxiaojun@163.com
Qi shaoyan, Master, +8613523500988, qishaoyan1970@163.com
About this study
Official title: A Randomized Controlled Pilot Trial of When Heparin Stopped for Anticoagulation During Extracorporeal Membrane Oxygenation Decannulation
Heparin (regular or unfractionated heparin, not low molecular weight heparin) is given as a bolus (50-100 units per kilogram) at the time of extracorporeal membrane oxygenation(ECMO) cannulation, and by continuous infusion during ECMO. Heparin infusion is regulated to keep the whole blood activated clotting time (ACT) or activated partial thromboplastin time (APTT) at a designated level (usually 1.5 times normal for the ACT or APTT measurement system). An elevated ACT or APTT is associated with high risks of early and late complications,such as bleeding,hematoma,pseudoaneurysm,and arterial-venous fistula. Extracorporeal life support organization(ELSO) make recommendation that the cannulas can be removed ideally after the heparin has been stopped for 30 to 60 minutes.However,the Chinese Thoracis Society recommends that heparin should not be discontinued immediately before ECMO decannulation, but gradually reduced within 24 hours, and then low molecular weight heparin is continued to be given for anticoagulation. Therefore,options of which time heparin stopped remain controversial.The investigators conduct this pilot study to investigate the opportunity of heparin stopped for anticoagulation before ECMO decannulation.
Read the detailed description
Forty adult patients with cardiac or respiratory failure supported by ECMO are enrolled in the study. Patients are randomly allocated to be treated with either a) heparin has been stopped for 1 hour before ECMO decannulation(regimen A), b) heparin gradually reduced within 24 hours after ECMO decannulation(regimen B).The investigators hypothesize that patients treated with regimen A as compared with patients treated with regimen B would decrease the incidence of complications during the ECMO decannulation period(from 1 hour before ECMO decannulation to 72 hours post decannulation).
- Conditions
- Extracorporeal Membrane Oxygenation
- Being tested
- Heparin stopped before ECMO decannulation, Heparin reduced after ECMO decannulation
- Keywords
- Extracorporeal Membrane Oxygenation, Heparin, Anticoagulants, Decannulation, Randomized Controlled
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heparin stopped before ECMO decannulationOther
Heparin has been stopped for 1 hour before ECMO decannulation;The cannulas can be removed immediately with clots larger than 5 mm or enlarging clots in the circuit.
Heparin reduced after ECMO decannulationOther
Heparin gradually reduced within 24 hours after ECMO decannulation, If excess bleeding occured,decrease the heparin infusion rapidly or turn the heparin off immediately. Protamine can be given to reversing heparin if necessary.
| Study group | Role | What they receive |
|---|---|---|
| Previous | Experimental | Heparin stopped before ECMO decannulation Receives: Other: Heparin stopped before ECMO decannulation |
| Afterwards | Experimental | Heparin reduced after ECMO decannulation Receives: Other: Heparin reduced after ECMO decannulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of bleeding and clotting complications
Measured: 72 hours after decannulation
Secondary outcomes (13)
ICU mortality
Measured: 1 day after ICU discharge
28-days mortality
Measured: 28 days after decannulation
Prothrombin time
Measured at the laboratory
Measured: 1 day and 3 days after decannulation
Activated partial thromboplastin time
Measured at the laboratory
Measured: 1 day and 3 days after decannulation
International normalised ratio
Measured at the laboratory
Measured: 1 day and 3 days after decannulation
Fibrinogen
Measured at the laboratory
Measured: 1 day and 3 days after decannulation
D-dimer
Measured at the laboratory
Measured: 1 day and 3 days after decannulation
R time
Time to initial fibrin formation in minutes
Measured: 1 day and 3 days after decannulation
K time
Minutes to 20 mm clot strength
Measured: 1 day and 3 days after decannulation
α angle
Rate of clot strengthening
Measured: 1 day and 3 days after decannulation
Maximum amplitude（MA）
MA represents the ultimate strength of the fibrin clot in mm
Measured: 1 day and 3 days after decannulation
LY30
Degree of clot lysis at 30 minutes
Measured: 1 day and 3 days after decannulation
Volume of packed red cells transfusion
Measured: 3 days after decannulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start15 Feb 2022
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Extracorporeal Membrane OxygenationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Zhengzhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li yahui, Master, Principal investigator, Second Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05239637
- Sponsor's protocol ID
- LHGJ20210421
- Status last verified
- Feb 2022
- First submitted
- 21 Dec 2021
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tonna JE, Abrams D, Brodie D, Greenwood JC, Rubio Mateo-Sidron JA, Usman A, Fan E. Management of Adult Patients Supported with Venovenous Extracorporeal Membrane Oxygenation (VV ECMO): Guideline from the Extracorporeal Life Support Organization (ELSO). ASAIO J. 2021 Jun 1;67(6):601-610. doi: 10.1097/MAT.0000000000001432.
PubMed 33965970
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Pilot Trial of When Heparin Stopped for Anticoagulation During Extracorporeal Membrane Oxygenation Decannulation
- ClinicalTrials.gov ID
- NCT05239637
- Acronym / sponsor ID
- LHGJ20210421
- Conditions
- Extracorporeal Membrane Oxygenation
- Keywords
- Extracorporeal Membrane Oxygenation, Heparin, Anticoagulants, Decannulation, Randomized Controlled
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 15 Feb 2022 (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.
Heparin (regular or unfractionated heparin, not low molecular weight heparin) is given as a bolus (50-100 units per kilogram) at the time of extracorporeal membrane oxygenation(ECMO) cannulation, and by continuous infusion during ECMO. Heparin infusion is regulated to keep the whole blood activated clotting time (ACT) or activated partial thromboplastin time (APTT) at a designated level (usually 1.5 times normal for the ACT or APTT measurement system). An elevated ACT or APTT is associated with high risks of early and late complications,such as bleeding,hematoma,pseudoaneurysm,and arterial-venous fistula. Extracorporeal life support organization(ELSO) make recommendation that the cannulas can be removed ideally after the heparin has been stopped for 30 to 60 minutes.However,the Chinese Thoracis Society recommends that heparin should not be discontinued immediately before ECMO decannulation, but gradually reduced within 24 hours, and then low molecular weight heparin is continued to be given for anticoagulation. Therefore,options of which time heparin stopped remain controversial.The investigators conduct this pilot study to investigate the opportunity of heparin stopped for anticoagulation before ECMO decannulation.
Detailed description
Forty adult patients with cardiac or respiratory failure supported by ECMO are enrolled in the study. Patients are randomly allocated to be treated with either a) heparin has been stopped for 1 hour before ECMO decannulation(regimen A), b) heparin gradually reduced within 24 hours after ECMO decannulation(regimen B).The investigators hypothesize that patients treated with regimen A as compared with patients treated with regimen B would decrease the incidence of complications during the ECMO decannulation period(from 1 hour before ECMO decannulation to 72 hours post decannulation).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Previous | Experimental | Other: Heparin stopped before ECMO decannulationHeparin stopped before ECMO decannulation |
| Afterwards | Experimental | Other: Heparin reduced after ECMO decannulationHeparin reduced after ECMO decannulation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ECMO therapy was instituted to support circulatory and/or respiratory failure;
- Heparin continuous infusion for anticoagulation during ECMO;
- Native cardiac and pulmonary function improve,and the trial off is successful.
- Ensure each patient provides signed and dated informed consent.
Key exclusion criteria (9 listed)
- 1.History of thrombotic diseases or coagulation disorder；
- Thrombosis or bleeding events occurred prior to allocation；
- Heparin stopped prior to allocation；
- Other anticoagulants, antiplatelets, hemostatics and other drugs affected coagulation function have been used；
- The trial off has failed;
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 |
|---|---|---|
| Heparin stopped before ECMO decannulationHeparin has been stopped for 1 hour before ECMO decannulation;The cannulas can be removed immediately with clots larger than 5 mm or enlarging clots in the circuit. | Other | Previous |
| Heparin reduced after ECMO decannulationHeparin gradually reduced within 24 hours after ECMO decannulation, If excess bleeding occured,decrease the heparin infusion rapidly or turn the heparin off immediately. Protamine can be given to reversing heparin if necessary. | Other | Afterwards |
Primary outcome
Incidence of bleeding and clotting complications
Time frame: 72 hours after decannulation
13 secondary outcomes
ICU mortality
Time frame: 1 day after ICU discharge
28-days mortality
Time frame: 28 days after decannulation
Prothrombin time
Time frame: 1 day and 3 days after decannulation
Activated partial thromboplastin time
Time frame: 1 day and 3 days after decannulation
International normalised ratio
Time frame: 1 day and 3 days after decannulation
Fibrinogen
Time frame: 1 day and 3 days after decannulation
D-dimer
Time frame: 1 day and 3 days after decannulation
R time
Time frame: 1 day and 3 days after decannulation
K time
Time frame: 1 day and 3 days after decannulation
α angle
Time frame: 1 day and 3 days after decannulation
Maximum amplitude（MA）
Time frame: 1 day and 3 days after decannulation
LY30
Time frame: 1 day and 3 days after decannulation
Volume of packed red cells transfusion
Time frame: 3 days after decannulation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Background: PubMed 33965970Tonna JE, Abrams D, Brodie D, Greenwood JC, Rubio Mateo-Sidron JA, Usman A, Fan E. Management of Adult Patients Supported with Venovenous Extracorporeal Membrane Oxygenation (VV ECMO): Guideline from the Extracorporeal Life Support Organization (ELSO). ASAIO J. 2021 Jun 1;67(6):601-610. doi: 10.1097/MAT.0000000000001432.
- 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. This study is not recruiting at the moment.
Li yahui, Master principal investigator
Second Affiliated Hospital of Zhengzhou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heparin stopped before ECMO decannulation and Heparin reduced after ECMO decannulation in people with Extracorporeal Membrane Oxygenation, run by Second Affiliated Hospital of Zhengzhou University 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 9 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: status not confirmed, as of the sponsor's last update on 15 Mar 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li yahui, Master (+8618530060930, zdyxyliyahui@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of bleeding and clotting complications (time frame: 72 hours after decannulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05239637, which also lists 1 linked publication.
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 15 Mar 2022; AzTrials last refreshed its copy on 29 Oct 2026.