Antithrombin Supplementation in ECMO

NCT03208270 | Completed Phase 2

• 2 other identifiers: GATRA20162016-004534-23
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

Bleeding is the most feared complication during extracorporeal membrane oxygenation (ECMO) and is associated with high dosing of heparin. There is no consensus on antithrombin (AT) supplementation during ECMO. However, AT is needed by heparin to properly anticoagulate. We hypothesize that maintaining normal antithrombin levels during ECMO is associated with a less heparin dosing and more adequate level of anticoagulation.

Conditions

Extracorporeal Membrane Oxygenation

Outcome Measures

Primary Outcomes (1)

• Amount of heparin

  Heparin dosage to maintain aPTT ratio between 1.5-2

  through study completion, an average of 10 days

Secondary Outcomes (4)

• Bleeding

  through study completion, an average of 10 days

• Adequacy of anticoagulation

  through study completion, an average of 10 days

• thrombosis

  through study completion, an average of 10 days

• transfusions

  through study completion, an average of 10 days

Study Arms (2)

Antithrombin supplementation

EXPERIMENTAL

Patients randomized to the study group will receive supplementation of antithrombin concentrate to maintain a functional antithrombin level between 80%-120%.

Drug: Antithrombin supplementation

No Antithrombin supplementation

ACTIVE COMPARATOR

Patients randomized to the control group will never receive supplementation of antithrombin unless "heparin resistance" occurs.

Drug: No antithrombin supplementation

Interventions

Antithrombin supplementation DRUG

antithrombin concentrate will be supplemented to maintain a functional antithrombin level between 80%-120%

Also known as: Antithtrombin

Antithrombin supplementation

No antithrombin supplementation DRUG

supplementation of antithrombin will not be provided unless "heparin resistance" occurs

Also known as: No antithrombin

No Antithrombin supplementation

Eligibility Criteria

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

You may qualify if:

• patients requiring veno-venous ECMO for severe respiratory failure.

You may not qualify if:

• patients with pre-existent heparin-induced thrombocytopenia

Sponsors & Collaborators

• Policlinico Hospital: lead
• The Mediterranean Institute for Transplantation and Advanced Specialized Therapies: collaborator

Study Sites (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, MI, 20122, Italy

Location

Related Publications (2)

• Panigada M, Spinelli E, De Falco S, Consonni D, Novembrino C, Boscolo Anzoletti M, Panarello G, Occhipinti G, Dos Santos CC, Pesenti A, Arcadipane A, Grasselli G. The relationship between antithrombin administration and inflammation during veno-venous ECMO. Sci Rep. 2022 Aug 22;12(1):14284. doi: 10.1038/s41598-022-17227-7.

  PMID: 35995816 DERIVED

• Panigada M, Spinelli E, Cucino A, Cipriani E, De Falco S, Panarello G, Occhipinti G, Arcadipane A, Sales G, Fanelli V, Brazzi L, Novembrino C, Consonni D, Pesenti A, Grasselli G. Antithrombin supplementation during extracorporeal membrane oxygenation: study protocol for a pilot randomized clinical trial. Trials. 2019 Jun 11;20(1):349. doi: 10.1186/s13063-019-3386-4.

  PMID: 31186035 DERIVED

Study Officials

• Mauro Panigada, MD

  Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 1, 2017
• First Posted: July 5, 2017
• Study Start: July 28, 2017
• Primary Completion: May 15, 2019
• Study Completion: May 15, 2019
• Last Updated: May 17, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)