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Acute Aortic DissectionNCT01894334

Mechanism and Early Intervention Research on ALI During Emergence Surgery of Acute Stanford A Aortic Dissection

A study testing Ulinastatin, Tranexamic acid and Edaravone in people with Acute Aortic Dissection, run by Beijing Anzhen Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The morbidity rate of Stanford A type Acute Aortic Dissection（AAD） has been increasing, about 5-10/100,000* per year. Emergency surgery has been the main treatment for Acute Aortic Dissection, however perioperative mortality rate can be as high as 15~30%. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Acute Aortic Dissection
What is being tested?
Ulinastatin, Tranexamic acid and Edaravone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
No sites listed yet
Study dates
Apr 2013to Jan 2015
Phase
Interventional
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 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • AAD patients within 48 hrs of onset who are prepared for aortic surgery
  • Age between 18 and 70
  • Willing to sign the informed consent

Who cannot join

  • A history of chronic respiratory disease before onset
  • A history of chronic heart failure or coronary heart disease before onset
  • A history of chronic liver or kidney dysfunction before onset
  • Severe central nervous system syndrome after admission
  • Refuse to sign the informed consent

About this study

Official title: Mechanism and Early Intervention Research on Acute Lung Injury During Emergence Surgery of Acute Stanford A Aortic Dissection

The morbidity rate of Stanford A type Acute Aortic Dissection（AAD） has been increasing, about 5-10/100,000* per year. Emergency surgery has been the main treatment for Acute Aortic Dissection, however perioperative mortality rate can be as high as 15~30%. Acute lung injury (ALI) is one of the main complications that happen during the perioperative period, which by itself covers 30%-50% of the overall mortality rate. Both domestic and foreign countries lack researches on risk factors, pathogenesis, disease progression and outcome of ALI, which happen during the perioperative period of Acute Aortic Dissection patients.

This topic study follow projects in the preoperative of Acute Aortic Dissection'surgery

Read more
  1. hemodynamic changes (aortic dissection resulting in acute aortic regurgitation, cardiac tamponade and proximal high blood pressure)
  2. ischemia - reperfusion injury of aortic dissection distal organ
  3. Aortic intima-media exposure cause coagulation / fibrinolytic system function disorder
  4. systemic inflammatory response syndrome; use relevant clinical radiographic parameters, indicators of respiratory mechanics (oxygenation index and lung injury index) and biochemical indicators.

To discuss risk factors and possible mechanisms of ADD patients with pre-operative ALI and observe their influences on the progress and prognosis of AAD, to explore early intervention in the preoperative for possible risk factors and mechanisms and to evaluate their influences on the prognosis, to achieve the purpose of reducing AAD perioperative mortality of ALI and medical expenses.

Being tested
Ulinastatin, Tranexamic acid, Edaravone
Keywords
Aortic dissection, acute lung injury, injury mechanism, early intervention
Medical subject headings
Aortic Dissection, Acute Lung Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01894334
Study groupRoleWhat they receive
Control groupNo interventionno intervention
Tranexamic acid groupExperimentaltranexamic acid ，intravenous 30mg/kg/d，Preoperative
Receives: Drug: Tranexamic acid
Edaravone groupExperimentaledaravone, iv, 1mg/kg/d,Preoperative
Receives: Drug: Edaravone
Ulinastatin groupExperimentalUlinastatin ,iv，20,000 U /kg/d，Preoperative
Receives: Drug: Ulinastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. perioperative outcome and improve of ALI

    indicators

    • chest imaging (preoperative, 12 hours after ICU);
    • arterial blood gases and alveolar-arterial oxygen difference (before surgery, and immediately after induction of anesthesia, before surgery ends and 12 hours after ICU);
    • respiratory mechanics (immediately after induction of anesthesia, before the end of surgery and 12 hours after ICU); including peak airway pressure, plateau pressure, dynamic and static compliance and so on.

    Measured: Period from 48 hours before surgery to 12 hours after ICU

Secondary outcomes (1)

  1. systemic inflammatory response

    Indicators

    • Lung lavage (immediately after induction of anesthesia、before the end of surgery)
    • determination of imflammatory cytokines (IL-6, IL-8, Tumor Necrosis Factor -α, Cluster of Differentiation 11 /Cluster of Differentiation 18 , myeloperoxidase) and surface-active substance

    Measured: Period from 48 hours before surgery to 12 hours after ICU

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionJan 2015 (estimated)
  4. Study completionJan 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01894334
Sponsor's protocol ID
2011-2006-03
Status last verified
Jan 2014
First submitted
8 Jun 2013
Last updated
24 Jan 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Gao Z, Pei X, He C, Wang Y, Lu J, Jin M, Cheng W. Oxygenation impairment in patients with acute aortic dissection is associated with disorders of coagulation and fibrinolysis: a prospective observational study. J Thorac Dis. 2019 Apr;11(4):1190-1201. doi: 10.21037/jtd.2019.04.32.

    PubMed 31179061

  • Pan X, Lu J, Cheng W, Yang Y, Zhu J, Jin M. Independent factors related to preoperative acute lung injury in 130 adults undergoing Stanford type-A acute aortic dissection surgery: a single-center cross-sectional clinical study. J Thorac Dis. 2018 Jul;10(7):4413-4423. doi: 10.21037/jtd.2018.06.140.

    PubMed 30174890

  • Cheng Y, Jin M, Dong X, Sun L, Liu J, Wang R, Yang Y, Lin P, Hou S, Ma Y, Wang Y, Pan X, Lu J, Cheng W. Mechanism and early intervention research on ALI during emergence surgery of Stanford type-A AAD: Study protocol for a prospective, double-blind, clinical trial. Medicine (Baltimore). 2016 Oct;95(42):e5164. doi: 10.1097/MD.0000000000005164.

    PubMed 27759648

Questions about this trial

What is this clinical trial studying?

A study testing Ulinastatin, Tranexamic acid and Edaravone in people with Acute Aortic Dissection, run by Beijing Anzhen Hospital.

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 3 inclusion and 5 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 24 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

perioperative outcome and improve of ALI (time frame: Period from 48 hours before surgery to 12 hours after ICU). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01894334, which also lists 3 linked publications.

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 24 Jan 2014.

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