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Plasma Transfusion in Major Vascular Surgery

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ClinicalTrials.gov Identifier: NCT04514575
Recruitment Status : Completed
First Posted : August 17, 2020
Last Update Posted : January 28, 2021
Sponsor:
Collaborator:
Statens Serum Institut
Information provided by (Responsible Party):
Naestved Hospital

Brief Summary:

BACKGROUND

  • Major blood loss is frequent in open repair of ruptured and intact abdominal aortic aneurysm (AAA) as well as in aorto-bifurcated prosthesis insertion due to aortoiliac occlusive disease.
  • Major blood loss is associated with death, post-operative complications and coagulopathy.
  • Data from randomized trials in trauma patients indicate that a high plasma to red blood cell (RBC) transfusion ratio reduces 30-day mortality.
  • No randomized trial data are available for the AAA population.
  • Observational data demonstrate, that a high plasma:RBC transfusion ratio associates to a lower 30 day mortality. However, the reports are based on small cohorts of 78-165 patients, short term outcomes and lack information on major adverse events such as cardiac and respiratory.
  • The Danish Vascular Registry (DVR), covering 1996-2018, contains data on approx. 4,400 ruptured and 8,200 intact (elective/symptomatic) AAA repairs, and 5,400 open aortoiliac repairs due to occlusive disease. Expected total count 1997-2018: 17,000.
  • The Danish Transfusion Database (DTDB), covering approx. 1997-2018, contains information on units of RBCs, plasma and platelets transfused. A unique patient identification number (CPR) allows merging of all data set.

OBJECTIVE

To identify whether resuscitation with a high plasma to RBC ratio associates to improves survival in open abdominal aortic surgery as compared to a low plasma to RBC-ratio.

PICO

  • Population: Open abdominal aortic surgery
  • Intervention: "High FFP": FFP to RBC unit ratio of 2:3 to 3:3 (0.7 - 1.0)
  • Comparison: "Low FFP": FFP to RBC unit ratio of 0:3 to 1:3 (0.0 - 0.3)
  • Outcome: All-cause mortality 90 days following surgery.

DATA SOURCES

CPR, Danish Civil Registration System. DNPR, Danish National Patient registry. DVR, Danish Vascular registry. DPDB, The Danish national Prescription DataBase.


Condition or disease Intervention/treatment
Aortic Aneurysm, Abdominal Arterial Occlusive Diseases Biological: Plasma transfusion

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Study Type : Observational
Actual Enrollment : 17000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Plasma Transfusion in Major Vascular Surgery: a Danish Nationwide Registry Study
Actual Study Start Date : January 1, 1997
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
High-FFP
Patients transfused with an FFP:RBC ratio of 2:3 to 3:3 (0.7 - 1.0)
Biological: Plasma transfusion
Transfusion of allogeneic fresh frozen plasma or cryoprecipitate

Low-FFP
Patients transfused with an FFP:RBC ratio at or below 1:3 (0.0 - 0.3).
Biological: Plasma transfusion
Transfusion of allogeneic fresh frozen plasma or cryoprecipitate




Primary Outcome Measures :
  1. 90-day survival [ Time Frame: First 90 days after index surgery ]
    Survival data. Source: CPR


Secondary Outcome Measures :
  1. 30-day survival [ Time Frame: First 30 days after index surgery ]
    Survival data. Source: CPR

  2. 1-year survival [ Time Frame: 1 year after index surgery ]
    Survival data. Source: CPR

  3. Death or any major adverse events at 90-days [ Time Frame: First 90 days after index surgery ]

    Dichotomous outcome. Source: DNPR and DVR.

    A. Major adverse cardiovascular events "MACE" [ICD10-codes]

    • acute myocardial infarction [DI21.0-23.9, DT817Y2]
    • stroke [DI60-64.9, DT817Y1]
    • non-fatal cardiac arrest [DI460]

    B. Major adverse respiratory events

    • adult respiratory distress syndrome [DJ80]
    • pulmonary edema [DJ81]
    • pulmonary embolism [DI26, DT817D]

    C. Major adverse vascular event

    • bowel ischemia [DK550C-H]
    • vascular reoperation for deep rebleeding or thrombus or embolus [KPWE, KPWG], lower-limb fasciotomy [KNGM09, KNHM09, KNFM09] or explorative laparotomy [KJAH00]
    • major lower limb amputation [KNE-HQ]
    • acute limb ischemia requiring intervention

    D. Other

    • renal replacement therapy [BJFD, DZ992]
    • AB0-incompatibility reaction [DT803]
    • Rhesus-incompatibility reaction [DT804]
    • Hemorrhage and hematoma complicating a procedure, not elsewhere classified [T810, DT810G, DT810E]

  4. Number of days alive outside hospital within 90 days [ Time Frame: Day 90 after index surgery ]
    Count data. Source: DNPR and CPR



Information from the National Library of Medicine

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Ages Eligible for Study:   41 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

In Denmark, every citizen is registered with a unique identification number in the Civil Registration System. Patients undergoing major open abdominal aortic surgery (above 40 and below 100 years of age) registered in the Danish Vascular Registry in the period between January 1st 1997 and December 31st 2018 will be identified and linked to national health registers by using the unique identification number. The DTDB will provide data on blood transfusions. The DNPR will provide data on complications by ICD10 code and on hospital admission duration.

Data sources CPR, Danish Civil Registration System. DNPR, Danish National Patient registry. DVR, Danish Vascular registry. DPDB, The Danish national Prescription DataBase.

Criteria

Inclusion Criteria:

  1. Open abdominal aortic repair with the insertion of prosthesis for either

    • intact (elective or symptomatic) AAA
    • ruptured AAA
    • aorto-iliac occlusive disease
  2. Requiring massive transfusion defined as 10 units or more of any blood product(*) transfused on the same date (source DTDB)

(*) = Allogeneic packed RBCs, FFP, cryoprecipitate, or platelets. Cryoprecipitate will account for 4 units of FFP in the FFP:RBC ratio.

Exclusion Criteria:

  1. Surgery time limited to < 50 minutes (DVR)
  2. No prosthesis inserted (DVR) AND operation date (DVR) equal to the death date (CPR)

Excluding patients with surgery time less than 50 minutes or cases where no prosthesis has been inserted is expected to minimize survival bias from patients exsanguinating in the operation theater before blood products can be delivered. Intentionally, it may also exclude cases where surgery was considered futile and halted.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04514575


Locations
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Denmark
Slagelse Hospital
Slagelse, Region Zealand, Denmark, 4200
Sponsors and Collaborators
Naestved Hospital
Statens Serum Institut
Investigators
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Study Director: Ole Pedersen, MD, PhD Department of Clinical Immunology, Naestved Hospital, Denmark.
  Study Documents (Full-Text)

Documents provided by Naestved Hospital:
Publications:

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Responsible Party: Naestved Hospital
ClinicalTrials.gov Identifier: NCT04514575    
Other Study ID Numbers: REG-144-2017
First Posted: August 17, 2020    Key Record Dates
Last Update Posted: January 28, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Arterial Occlusive Diseases
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases