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WithdrawnNCT03497338Updated Apr 1, 2021

New Anticoagulation Strategies of VV-ECMO

An observational study in Hemorrhage, sponsored by Xiao Tang. Withdrawn at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-01.

Sponsored by Xiao Tang · Observational

Why this study was withdrawn
No participants enrolled
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
01

Study summary

Effective and normative anticoagulation is one of the most important components of Extracorporeal membrane oxygenation (ECMO) management. Excessive anticoagulation may lead to hemorrhage, which is the most common and serious complication. Currently, the most common factors for monitoring anticoagulation of ECMO are the activated clotting time (ACT) and activated partial thromboplastin time (APTT). However, there is a lack of a unified understanding of the related monitoring measures, monitoring targets, and bleeding risk assessments, which have been chosen mainly because of experiences reported by various ECMO centers or the results of retrospective studies.Therefore, anticoagulation strategies need to be improved. Our research have found ECMO anticoagulation management should be transformed from monitoring only the APTT/activated clotting time (ACT) to considering the entire coagulation process. To maintain thrombosis ability and PLT function within normal ranges may help reduce hemorrhage rates and improve prognoses. This randomized controlled study aim to develop the safety and efficacy new anticoagulation strategies of VV-ECMO.

02

Conditions studied

  • Hemorrhage

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

the patients received ECMO support

Inclusion criteria

  • age more than 18 years old, VV-ECMO is estimated more than 3 days

Exclusion criteria

Exclusion Criteria:

  • hemorrhage before VV-ECMO established, VV-ECMO more than 48 hours before admitted, VV-ECMO is estimated less than 3 days
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Target follow-up
4 Weeks
Patient registry
Yes
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What researchers measure

Primary outcomes

  1. Percentage of Participants with hemorrhage events

    1) fatal bleeding; 2) symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome; and/or 3. bleeding causing a drop in hemoglobin level by 20 g/L or more or requiring transfusion of two units of whole blood or red cells.

    Time frame: 4 weeks

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Study locations

1 site
  • Department of respiratory and critical care medicine,Beijing Chao-yang Hospital
    Beijing, Beijing 100020, China
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT03497338
Lead sponsor
Xiao Tang
Responsible party
Xiao Tang (Principal Investigator, Beijing Chao Yang Hospital) — Sponsor-investigator
First posted
Apr 13, 2018
Start date
Apr 1, 2018
Primary completion
Mar 30, 2021
Completion
Mar 30, 2021
Last update
Apr 1, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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