PGE1 as Additive Anticoagulant in ECMO-Therapy

NCT02895373 | Terminated Phase 2

• 1 other identifier: ECMO_PGE1_2.1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Respiratory Distress Syndrome, Adult; Extracorporeal Membrane Oxygenation

Keywords

platelet inhibition; alprostadil; extracorporeal membrane oxygenation; bleeding; thromboembolic

Outcome Measures

Primary Outcomes (1)

• Bleeding rate (quantified by the number of packed red blood cells transfused in relation to the duration of ECMO therapy)

  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.

  up to 6 months

Secondary Outcomes (18)

• number of bleeding incidences and severity of bleeding (bleeding grades)

  up to six months

• Number of Clotting Events

  up to six months

• Function of the membrane oxygenator

  up to six months

• Number of changes of the membrane oxygenator relative to the duration of ECMO therapy

  up to six months

• 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

Study Arms (2)

Alprostadil

EXPERIMENTAL

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

Drug: Alprostadil

Placebo

PLACEBO COMPARATOR

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

Drug: 0.9% sodium chloride solution

Interventions

Alprostadil DRUG

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

Alprostadil

0.9% sodium chloride solution DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• minimum age 18 years
• Veno-Venous- ECMO
• Minimum of 24h planned ECMO- therapy

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Staudinger: lead

Study Sites (1)

Medical University of Vienna, Department of Medicine I, Intensive Care Unit

Vienna, 1090, Austria

Location

Related Publications (1)

• Buchtele N, Schorgenhofer C, Schwameis M, Jilma B, Schellongowski P, Herkner H, Riss K, Schmid M, Hermann A, Robak O, Nagler B, Traby L, Bojic A, Staudinger T. Add-On Prostaglandin E1 in Venovenous Extracorporeal Membrane Oxygenation: A Randomized, Double-Blind, Placebo-controlled Pilot Trial. Am J Respir Crit Care Med. 2022 Jul 15;206(2):170-177. doi: 10.1164/rccm.202110-2359OC.

  PMID: 35426776 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome; Hemorrhage

Interventions

Alprostadil; Sodium Chloride

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Fatty Acids, Monounsaturated; Autacoids; Inflammation Mediators; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Thomas Staudinger, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ao.Univ.Prof. Dr. med

Study Record Dates

• First Submitted: June 30, 2016
• First Posted: September 9, 2016
• Study Start: July 1, 2016
• Primary Completion: May 1, 2021
• Study Completion: July 1, 2021
• Last Updated: February 9, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)