Trial · NCT02895373
PGE1 as Additive Anticoagulant in ECMO-Therapy
NCT02895373, Phase 2, Terminated, Thomas Staudinger
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. PGE1 as Additive Anticoagulant in ECMO-Therapy. Trials, record NCT02895373. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02895373
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PGE1 as Additive Anticoagulant in ECMO-Therapy
- NCT number
- NCT02895373
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 50 participants, actual
- Lead sponsor
- Thomas Staudinger
- Conditions
- Respiratory Distress Syndrome, Adult, Extracorporeal Membrane Oxygenation
- Interventions
- Alprostadil, 0.9% sodium chloride solution
- First posted
- 2016-09-09
- Last updated
- 2022-02-09
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35426776 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02895373
GET https://conductscience.org/api/trials/v1/NCT02895373/registered