Trial · NCT02895373
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Bleeding rate (quantified by the number of packed red blood cells transfused in relation to the duration of ECMO therapy) | up to 6 months | The bleeding rate will be quantified by the number of packed red blood cells in relation to the duration of ECMO therapy. This duration may vary and cannot be predicted. Thus, we will calculate the required number of packed red blood cells i.e. per week. |
| Secondary | number of bleeding incidences and severity of bleeding (bleeding grades) | up to six months | type 0: no bleeding type1: bleeding that is not actionable type 2: any overt actionable sign of hemorrhage type3: a) overt bleeding plut hb drop of 3-5g/dl b) \>5g/dl, cardiac tamponade, requiring surgical intervention, bleeding requiring vasoactive agents c)intracranial bleeding, type 5: fatal bleeding number and severity of bleeding relative to the duration of ECMO therapy |
| Secondary | Number of Clotting Events | up to six months | * clinically noticeable thromboembolic events * cannulized veins (Duplex 24h after canula removal) * need of Membrane- changes,, macroscopic thrombus, discoloration * Global clotting tests (prothrombin time, activated partial thromboplastin time, Fibrinogen, D-Dimer) number of Clotting events in relation to the duration of ECMO therapy. |
| Secondary | Function of the membrane oxygenator | up to six months | The function of the membrane oxygenator will be assessed on a daily basis as part of clinical routine.This includes the capacity of oxygen transfer and carbon-dioxide (CO2) transfer. |
| Secondary | Number of changes of the membrane oxygenator relative to the duration of ECMO therapy | up to six months | Membrane oxygenators need to be changed due to loss of function (cause by clotting etc.). |
| Secondary | Inflammation specific biomarkers (i.e. C-reactive protein, blood counts, reticulated platelets, etc.) | Time points: Immediately prior to initiation of ECMO, 24, 48 and 72h after initiation of ECMO, then twice a week until end of ECMO therapy, up to 12 months | daily routine measurements and frozen plasma |
| Secondary | Global Coagulation assays | Time points: Immediately prior to initiation of ECMO, 24, 48 and 72h after initiation of ECMO, then twice a week until end of ECMO therapy, up to 12 months | |
| Secondary | Thromboelastometry | Time points: Immediately prior to initiation of ECMO, 24, 48 and 72h after initiation of ECMO, then twice a week until end of ECMO therapy, up to 12 months | |
| Secondary | platelet function analyzer-100 | Time points: Immediately prior to initiation of ECMO, 24, 48 and 72h after initiation of ECMO, then twice a week until end of ECMO therapy, up to 12 months | |
| Secondary | Fibrinogen levels | Time points: Immediately prior to initiation of ECMO, 24, 48 and 72h after initiation of ECMO, then twice a week until end of ECMO therapy, up to 12 months | |
| Secondary | whole blood aggregometry | Time points: Immediately prior to initiation of ECMO, 24, 48 and 72h after initiation of ECMO, then twice a week until end of ECMO therapy, up to 12 months | |
| Secondary | D-Dimer levels | Time points: Immediately prior to initiation of ECMO, 24, 48 and 72h after initiation of ECMO, then twice a week until end of ECMO therapy, up to 12 months | |
| Secondary | Catecholamines | Time points: Immediately prior to initiation of ECMO, 24, 48 and 72h after initiation of ECMO, then twice a week until end of ECMO therapy, up to 12 months | need for and dose of catecholamines |
| Secondary | cardiac output | Time points: Immediately prior to initiation of ECMO, 24, 48 and 72h after initiation of ECMO, then twice a week until end of ECMO therapy, up to 12 months | |
| Secondary | blood pressure | Time points: Immediately prior to initiation of ECMO, 24, 48 and 72h after initiation of ECMO, then twice a week until end of ECMO therapy, up to 12 months | |
| Secondary | mortality | Day 28/90, ICU mortality assessed at the discharge from the Intensive Care unit, this will be up to 12 months after inclusion into the study | by chart review or telephone call |
| Secondary | number of platelet transfusions, fresh frozen plamsa, coagulation interventions etc. | up to six months | by chart review, number relative to the duration of ECMO therapy |
| Secondary | number of platelet transfusions | up to six months | by chart review, number relative to the duration of ECMO therapy |
| Secondary | number of coagulation interventions | up to six months | by chart review, number relative to the duration of ECMO therapy |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT02895373/registered