PGE1 as Additive Anticoagulant in ECMO-Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2021-07-31

Brief Summary

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Bleeding complications and thromboembolic complications are frequent during extracorporeal membrane oxygenation (ECMO). Retrospective data suggest that platelet inhibition using prostaglandins, in this case PGE1, may reduce thromboembolic complications without increasing the bleeding risk. This randomized, double-blind trial aims to investigate the effects of PGE1 on bleeding risk, thromboembolic complications and the function of the ECMO.

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Detailed Description

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Prostaglandins may inhibit platelet activation via the P2Y1 ADP receptor. Platelets may contribute to thromboembolic complications and coagulation activation during ECMO therapy. Retrospective data suggest that treatment with PGE1 may serve beneficial by reducing the amount of heparin needed for inhibition of coagulation activation, and by reducing the thromboembolic risk without increasing the risk of bleeding.

Inhibition of platelets via PGE1 (Alprostadil) may be interesting in this setting, because, in contrast to other platelet inhibitors, it has a very short half-life and platelets remain susceptible for activation by more potent agonists (i.e. thrombin, ADP). Thus, although reducing the contribution of platelets to coagulation activation, it may not affect safety of participating subjects.

This randomized, double-blind, placebo controlled trial will investigate whether treatment of patients with ECMO therapy proves beneficial.

Conditions

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Respiratory Distress Syndrome, Adult Extracorporeal Membrane Oxygenation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Alprostadil

heparin (dose adjusted to aptt 50-60s) + Alprostadil (=PGE1) 5ng/kg/min, continuously, start within 24h of initiation of ECMO therapy and end at the end of ECMO therapy

Group Type EXPERIMENTAL

Alprostadil

Intervention Type DRUG

5ng/kg/min, continuously, start within 24h of initiation of ECMO therapy and end at the end of ECMO therapy

Placebo

heparin (dose adjusted to aptt 50-60s) + 0.9% sodium chloride infusion, continuously, start within 24h of initiation of ECMO therapy and end at the end of ECMO therapy

Group Type PLACEBO_COMPARATOR

0.9% sodium chloride solution

Intervention Type DRUG

continuously, start within 24h of initiation of ECMO therapy and end at the end of ECMO therapy

Interventions

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Alprostadil

5ng/kg/min, continuously, start within 24h of initiation of ECMO therapy and end at the end of ECMO therapy

Intervention Type DRUG

0.9% sodium chloride solution

continuously, start within 24h of initiation of ECMO therapy and end at the end of ECMO therapy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* minimum age 18 years

* Veno-Venous- ECMO
* Minimum of 24h planned ECMO- therapy

Exclusion Criteria

* • Long- term therapy with other antiplatelet drugs including Acetyl Salicylic Acid

* known Heparin induced thrombocytopenia
* Bleeding diathesis = contraindication for heparin (e.g. GI-bleeding, Intracerebral bleeding)
* Platelets \< 50 G/L
* Thromboplastin time \< 50%
* Pregnancy
* Patient \< 18 years
* prothrombin time \<50%

Drop out criteria:

* Major bleeding (from Type 3 bleeding; see "primary objective")
* Occurrence of HIT (4 T- Score: Number of platelets, development over time, manifestation of thrombosis, other reasons for thrombocytopenia \[10\])
* Plt \< 50 G/l

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No