Disseminated Intravascular CoagulationNCT03577015
International Prospective Registry of Disseminated Intravascular Coagulation
An observational study of Disseminated Intravascular Coagulation, run by Marcella Muller at 1 site in Netherlands.
Trial summary
Objectives: to evaluate the current diagnostic and therapeutic approaches for sepis-associated disseminated intravascular coagulation (DIC) in a large prospective registry. Design: prospective, multicenter, international registry. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disseminated Intravascular Coagulation
- How many people
- 1,000 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Nov 2017to 1 Jun 2021
- How long will I take part?
- 28 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients 18 years or older with a condition potentially associated with DIC, admitted to the intensive care unit, will be eligible for the study. The maximal time-window allowed between the diagnosis of the disease and inclusion in the study will be 72 hours.
Who may be able to join
- admission to the intensive care unit
- 18 years or older
- AND one of the following conditions:
- sepsis/severe infection
- solid tumor
- hematological malignancy
Show all 9Show fewer
- trauma
- obstetric complications
- acute pancreatitis
Who cannot join
- -<18 years
Trial locations and contacts
1 site in 1 country.
Alessandro Squizzato, MD PhD contact
Netherlands1 site, 1 recruiting
- Recruiting
Academic Medical Center
Amsterdam, 1105 AZ
Marcella Muller, MD PhD, m.c.muller@amc.uva.nl
Nicole Juffermans, MD PhD, n.p.juffermans@amc.uva.nl
About this study
Official title: International Prospective Registry for the Diagnosis and Management of Disseminated Intravascular Coagulation in the Intensive Care Unit
Objectives: to evaluate the current diagnostic and therapeutic approaches for sepis-associated disseminated intravascular coagulation (DIC) in a large prospective registry.
Design: prospective, multicenter, international registry. Study population: patients 18 years or older with severe infection to be potentially associated with DIC will be eligible for the study. The clinical visits and monitoring of the patients will follow local routine practices. No specific imaging tests or laboratory evaluations will be required and patients will be evaluated and treated according to local policy. All the involved centers will be asked to update information on included patients at 2, 4, 6, 8, 10 and 28 days after severe infection diagnosis.
Read more
Study outcomes: The primary outcome of the study is the development of DIC. Secondary outcomes are thrombotic (arterial and venous) and bleeding events, overall mortality at 28 days.
Study sample, feasibility, and analysis plan: We plan to enroll a minimum of 1000 patients.
- Conditions
- Disseminated Intravascular Coagulation
- Keywords
- disseminated intravascular coagulation, sepsis, trauma, pancreatitis, malignancy, obstetric complication
- Medical subject headings
- Disseminated Intravascular Coagulation, Sepsis, Wounds and Injuries, Pancreatitis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| critically ill patients at risk for DIC | patients 18 years or older with a condition potentially associated with DIC, admitted to intensive care: severe infection/sepsis, solid tumor, hematologic malignancies, trauma, obstetric complications, acute pancreatitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
disseminated intravascular coagulation
occurence of disseminated intravascular coagulation:
International Society Thrombosis Hemostasis DIC score >4 points (range 0-8 points) items scored: platelet count, prothrombin time, fibrinogen related marker, fibrinogen level
Japanese Association for Acute Medicine DIC score >3 points (range 0-8)points items scored: inflammatory response, platelet count, prothrombin time, fibrinogen degradation products
Measured: 28 days
disseminated intravascular coagulation
occurence of disseminated intravascular coagulation:
Japanese Association for Acute Medicine DIC score >3 points (range 0-8)points items scored: inflammatory response, platelet count, prothrombin time, fibrinogen degradation products
Measured: 28 days
Secondary outcomes (4)
mortality
mortality rates in patient who develop or do not develop disseminated intravascular coagulation
Measured: 28 days
venous thromboembolic events
occurence of symptomatic venous thromboembolic events including pulmonary embolism and deep vein thrombosis (VTE) of the upper and lower limbs, visceral VTE, and cerebral VTE.
Measured: 28 days
Arterial thromboembolic events
occurence of arterial thromboembolic events including myocardial infarction, stroke, peripheral embolism
Measured: 28 days
Major and clinically-relevant non-major bleeding
occurence of major and clinically relevant non-major bleeding
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start1 Nov 2017
- Primary completion1 Apr 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disseminated Intravascular CoagulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Marcella Muller
- Sponsor type
- University, hospital or other
- Collaborators
- Università degli Studi dell'Insubria, University of Chieti, Ospedale S. Antonio, Poliambulanza Foundation Hospital, Manchester Royal Infirmary, Juntendo University
- Responsible party
- Sponsor-investigator, Marcella Muller, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Sabrina Boraso, MD, Principal investigator, OSPEDALE S. ANTONIO, Padova, ItalyMarcello Di Nisio, MD PhD, Principal investigator, University of Chieti, ItalyJecko Tachil, MD PhD, Principal investigator, Manchester Royal Infirmary, Manchester, EnglandPierluigi Ferretti, MD, Principal investigator, Fondazione Poliambulanza, Brescia, ItalyToshiaki Iba, MD PhD, Principal investigator, (Juntendo University, Department of Emergency and Disaster Medicine, Tokyo, Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03577015
- Sponsor's protocol ID
- 184/2017
- Status last verified
- Aug 2018
- First submitted
- 22 May 2018
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Prospective Registry for the Diagnosis and Management of Disseminated Intravascular Coagulation in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT03577015
- Acronym / sponsor ID
- 184/2017
- Conditions
- Disseminated Intravascular Coagulation
- Keywords
- disseminated intravascular coagulation, sepsis, trauma, pancreatitis, malignancy, obstetric complication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Marcella MullerUniversity, hospital or other
- Collaborators
- Università degli Studi dell'Insubria, University of Chieti, Ospedale S. Antonio, Poliambulanza Foundation Hospital, Manchester Royal Infirmary, Juntendo University
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 5 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives: to evaluate the current diagnostic and therapeutic approaches for sepis-associated disseminated intravascular coagulation (DIC) in a large prospective registry.
Design: prospective, multicenter, international registry. Study population: patients 18 years or older with severe infection to be potentially associated with DIC will be eligible for the study. The clinical visits and monitoring of the patients will follow local routine practices. No specific imaging tests or laboratory evaluations will be required and patients will be evaluated and treated according to local policy. All the involved centers will be asked to update information on included patients at 2, 4, 6, 8, 10 and 28 days after severe infection diagnosis.
Study outcomes: The primary outcome of the study is the development of DIC. Secondary outcomes are thrombotic (arterial and venous) and bleeding events, overall mortality at 28 days.
Study sample, feasibility, and analysis plan: We plan to enroll a minimum of 1000 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| critically ill patients at risk for DIC | – | –patients 18 years or older with a condition potentially associated with DIC, admitted to intensive care: severe infection/sepsis, solid tumor, hematologic malignancies, trauma, obstetric complications, acute pancreatitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients 18 years or older with a condition potentially associated with DIC, admitted to the intensive care unit, will be eligible for the study. The maximal time-window allowed between the diagnosis of the disease and inclusion in the study will be 72 hours.
Key inclusion criteria (9 listed)
- admission to the intensive care unit
- 18 years or older
- sepsis/severe infection
- solid tumor
- hematological malignancy
Key exclusion criteria (1 listed)
- -<18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
disseminated intravascular coagulation
Time frame: 28 days
occurence of disseminated intravascular coagulation: International Society Thrombosis Hemostasis DIC score >4 points (range 0-8 points) items scored: platelet count, prothrombin time, fibrinogen related marker, fibrinogen level Japanese Association for Acute Medicine DIC score >3 points (range 0-8)points items scored: inflammatory response, platelet count, prothrombin time, fibrinogen degradation products
disseminated intravascular coagulation
Time frame: 28 days
occurence of disseminated intravascular coagulation: Japanese Association for Acute Medicine DIC score >3 points (range 0-8)points items scored: inflammatory response, platelet count, prothrombin time, fibrinogen degradation products
4 secondary outcomes
mortality
Time frame: 28 days
venous thromboembolic events
Time frame: 28 days
Arterial thromboembolic events
Time frame: 28 days
Major and clinically-relevant non-major bleeding
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessandro Squizzato, MD PhD contact
Sabrina Boraso, MD principal investigator
OSPEDALE S. ANTONIO, Padova, Italy
Marcello Di Nisio, MD PhD principal investigator
University of Chieti, Italy
Jecko Tachil, MD PhD principal investigator
Manchester Royal Infirmary, Manchester, England
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disseminated Intravascular Coagulation, run by Marcella Muller at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alessandro Squizzato, MD PhD (alessandro.squizzato@uninsurbia.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disseminated intravascular coagulation (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2018.