Aortic Aneurysm, AbdominalNCT04514575
Plasma Transfusion in Major Vascular Surgery
An observational study of Aortic Aneurysm, Abdominal and Arterial Occlusive Diseases, run by Naestved Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 41 to 99 years
- Conditions the study is for
- Aortic Aneurysm, Abdominal, Arterial Occlusive Diseases
- What is being tested?
- Plasma transfusion
- How many people
- 17,000 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 1997to 31 Dec 2018
- 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 41 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Open abdominal aortic repair with the insertion of prosthesis for either
- intact (elective or symptomatic) AAA
- ruptured AAA
- aorto-iliac occlusive disease
- 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.
Who cannot join
- Surgery time limited to < 50 minutes (DVR)
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Plasma Transfusion in Major Vascular Surgery: a Danish Nationwide Registry Study
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.
Read more
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.
Read the detailed description
STATISTICAL ANALYSIS PLAN
The primary analysis will be a stratified cox regression model.
STRATIFICATION:
- type of surgery/condition (ruptured AAA vs intact AAA vs aorto-iliac occlusive disease, source: DVR)
- sex (CPR)
- Center (Rigshospitalet vs. Gentofte vs. Slagelse vs. Odense vs. Kolding vs. Aarhus vs. Viborg vs. Aalborg, source: DVR)
COVARIATE ADJUSTMENT:
- calendar time (DVR)
- age (CPR)
- Carlsons comorbidity index score (DNPR)
- Priority (Acute vs. Sub-acute vs. Elective, source: DVR)
- Use of anti-thrombotic drugs (DPDB). A covariate of 4 levels (ATC code is noted in parenthesis).
- None vs.
- Anti-platelet therapy
- acetylsalicylic acid (B01AC06) or
- dipyridamole (B01AC07, eg. persantin or asasantin)
- Anti-platelet therapy "thienopyridines-like drugs"
- clopidogrel (B01AC04) or
- ticagrelor (B01AC24, eg. Brilique) or
- prasugrel (B01AC22, eg. Efient) Comment: patients prescribed thienopyridines in combination with aspirin will be included in this "thienopyridine anti-platelet group 3"
- Anti-coagulant therapy
- Vitamin K antagonists (B01AA, eg. warfarin or phenprocoumon)
- Low-molecular weight heparine (B01AB01-10)
- Direct thrombin inhibitors (B01AE, eg. Pradaxa/Dabigatran)
- Direct factor Xa inhibitors (B01AF, eg. Rivaroxaban/Xarelto). Comment: patients prescribed both anticoagulant- and antiplatelet therapy and will be included in this "Anti-coagulant group 4".
ADDITIONAL ANALYSES:
- Stratify the population into 4 groups according to the total transfusion requirement
- patients receiving 10 units or less of any blood product < 24 hrs or 11-15 units < 48 hrs.vs.
- patients receiving 11-15 units of any blood product < 24 hrs. or 16-20 units < 48 hrs. vs.
- patients receiving 16-20 units of any blood product < 24 hrs. or 21-25 units < 48 hrs. vs.
- patients receiving more than 20 units of any blood product < 24 hrs. or more than 25 units < 48 hrs.
- Outcome predicted by a joint function (general interaction) of total plasma transfusion and total blood cell transfusion will be assessed in an exploratory way by inspection and by agnostic modelling in the mold of Multivariate Adaptive Regression Splines (MARS) and recursive partitioning, i.e. Classification And Regression Trees (CART).
- Redefine intervention and control group as 4th and 1st quartile of FFP:RBC ratio. Initially, the population will be divide into 4 groups according to quartiles and compared the population below 1st quartile with the population above the 4th quartile, which will define the low vs. the high FFP group, resp. However, to allow for stratification for operation type (ruptured AAA vs. intact AAA vs. occlusive disease) it may be necessary to adjust the percentile cut to retain power in the analyses. For instance, the population may be cut according to tertiles, or, if there is sufficient data, cut by quintiles (5 groups) or deciles (10 groups).
- Confine the population to patient with blood loss above 50 % of total blood volume (calculated by Naddler's equation accounting for sex, weight and height). If height and weight are not available, the registered blood loss must exceed 2 L in females and 2.5 L in males.
- Adjusting exclusively for calendar year, sex, age, Charlson's comorbidity index score, and center (ie, excluding priority and antithrombotic therapy).
MISSING DATA
Missing data will not be an issue for the number of blood transfusions because units of blood products transfused are used as an inclusion criterion. All remaining covariates are discrete, and missing data for each of those will be included as separate parameters (factor level).
STATISTICAL SIGNIFICANCE LEVEL
Bonferroni adjustment of the significance level will be applied to control for multiple testing.
With one primary and four secondary outcomes, only a P-value below 0.01 (0.05/5) will be considered statistically significant. A P-value between 0.01 and 0.05 will be considered borderline significant.
- Being tested
- Plasma transfusion
- Medical subject headings
- Aortic Aneurysm, Abdominal, Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma transfusionBiological
Transfusion of allogeneic fresh frozen plasma or cryoprecipitate
| Study group | Role | What they receive |
|---|---|---|
| High-FFP | Patients transfused with an FFP:RBC ratio of 2:3 to 3:3 (0.7 - 1.0) Receives: Biological: Plasma transfusion | |
| Low-FFP | Patients transfused with an FFP:RBC ratio at or below 1:3 (0.0 - 0.3). Receives: Biological: Plasma transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
90-day survival
Survival data. Source: CPR
Measured: First 90 days after index surgery
Secondary outcomes (4)
30-day survival
Survival data. Source: CPR
Measured: First 30 days after index surgery
1-year survival
Survival data. Source: CPR
Measured: 1 year after index surgery
Death or any major adverse events at 90-days
Dichotomous outcome. Source: DNPR and DVR.
- 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]
- Major adverse respiratory events
- adult respiratory distress syndrome [DJ80]
- pulmonary edema [DJ81]
- pulmonary embolism [DI26, DT817D]
- 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
- 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]
Measured: First 90 days after index surgery
Number of days alive outside hospital within 90 days
Count data. Source: DNPR and CPR
Measured: Day 90 after index surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start1 Jan 1997
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Aortic Aneurysm, AbdominalStudies 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
- Retrospective
- Enrolment
- 17,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Naestved Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Statens Serum Institut
- Responsible party
- Sponsor
- Investigators
- Ole Pedersen, MD, PhD, Study director, Department of Clinical Immunology, Naestved Hospital, Denmark.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04514575
- Sponsor's protocol ID
- REG-144-2017
- Status last verified
- Jan 2021
- First submitted
- 30 Jun 2020
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Desborough M, Sandu R, Brunskill SJ, Doree C, Trivella M, Montedori A, Abraha I, Stanworth S. Fresh frozen plasma for cardiovascular surgery. Cochrane Database Syst Rev. 2015 Jul 14;2015(7):CD007614. doi: 10.1002/14651858.CD007614.pub2.
PubMed 26171897Holcomb JB, Tilley BC, Baraniuk S, Fox EE, Wade CE, Podbielski JM, del Junco DJ, Brasel KJ, Bulger EM, Callcut RA, Cohen MJ, Cotton BA, Fabian TC, Inaba K, Kerby JD, Muskat P, O'Keeffe T, Rizoli S, Robinson BR, Scalea TM, Schreiber MA, Stein DM, Weinberg JA, Callum JL, Hess JR, Matijevic N, Miller CN, Pittet JF, Hoyt DB, Pearson GD, Leroux B, van Belle G; PROPPR Study Group. Transfusion of plasma, platelets, and red blood cells in a 1:1:1 vs a 1:1:2 ratio and mortality in patients with severe trauma: the PROPPR randomized clinical trial. JAMA. 2015 Feb 3;313(5):471-82. doi: 10.1001/jama.2015.12.
PubMed 25647203Johansson PI, Stensballe J, Rosenberg I, Hilslov TL, Jorgensen L, Secher NH. Proactive administration of platelets and plasma for patients with a ruptured abdominal aortic aneurysm: evaluating a change in transfusion practice. Transfusion. 2007 Apr;47(4):593-8. doi: 10.1111/j.1537-2995.2007.01160.x.
PubMed 17381616Mell MW, O'Neil AS, Callcut RA, Acher CW, Hoch JR, Tefera G, Turnipseed WD. Effect of early plasma transfusion on mortality in patients with ruptured abdominal aortic aneurysm. Surgery. 2010 Nov;148(5):955-62. doi: 10.1016/j.surg.2010.02.002. Epub 2010 Apr 7.
PubMed 20378142Mesar T, Larentzakis A, Dzik W, Chang Y, Velmahos G, Yeh DD. Association Between Ratio of Fresh Frozen Plasma to Red Blood Cells During Massive Transfusion and Survival Among Patients Without Traumatic Injury. JAMA Surg. 2017 Jun 1;152(6):574-580. doi: 10.1001/jamasurg.2017.0098.
PubMed 28273299Montan C, Hammar U, Wikman A, Berlin E, Malmstedt J, Holst J, Wahlgren CM. Massive Blood Transfusion in Patients with Ruptured Abdominal Aortic Aneurysm. Eur J Vasc Endovasc Surg. 2016 Nov;52(5):597-603. doi: 10.1016/j.ejvs.2016.07.023. Epub 2016 Sep 4.
PubMed 27605360Sperry JL, Guyette FX, Adams PW. Prehospital Plasma during Air Medical Transport in Trauma Patients. N Engl J Med. 2018 Nov 1;379(18):1783. doi: 10.1056/NEJMc1811315. No abstract available.
PubMed 30380388
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Transfusion in Major Vascular Surgery: a Danish Nationwide Registry Study
- ClinicalTrials.gov ID
- NCT04514575
- Acronym / sponsor ID
- REG-144-2017
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17,000 participants (actual)
- Lead sponsor
- Naestved HospitalUniversity, hospital or other
- Collaborators
- Statens Serum Institut
- Study start
- 1 Jan 1997 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 17 Aug 2020 (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.
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.
Detailed description
STATISTICAL ANALYSIS PLAN
The primary analysis will be a stratified cox regression model.
STRATIFICATION:
- type of surgery/condition (ruptured AAA vs intact AAA vs aorto-iliac occlusive disease, source: DVR)
- sex (CPR)
- Center (Rigshospitalet vs. Gentofte vs. Slagelse vs. Odense vs. Kolding vs. Aarhus vs. Viborg vs. Aalborg, source: DVR)
COVARIATE ADJUSTMENT:
- calendar time (DVR)
- age (CPR)
- Carlsons comorbidity index score (DNPR)
- Priority (Acute vs. Sub-acute vs. Elective, source: DVR)
- Use of anti-thrombotic drugs (DPDB). A covariate of 4 levels (ATC code is noted in parenthesis).
- None vs.
- Anti-platelet therapy
- acetylsalicylic acid (B01AC06) or
- dipyridamole (B01AC07, eg. persantin or asasantin)
- Anti-platelet therapy "thienopyridines-like drugs"
- clopidogrel (B01AC04) or
- ticagrelor (B01AC24, eg. Brilique) or
- prasugrel (B01AC22, eg. Efient) Comment: patients prescribed thienopyridines in combination with aspirin will be included in this "thienopyridine anti-platelet group 3"
- Anti-coagulant therapy
- Vitamin K antagonists (B01AA, eg. warfarin or phenprocoumon)
- Low-molecular weight heparine (B01AB01-10)
- Direct thrombin inhibitors (B01AE, eg. Pradaxa/Dabigatran)
- Direct factor Xa inhibitors (B01AF, eg. Rivaroxaban/Xarelto). Comment: patients prescribed both anticoagulant- and antiplatelet therapy and will be included in this "Anti-coagulant group 4".
ADDITIONAL ANALYSES:
- Stratify the population into 4 groups according to the total transfusion requirement
- patients receiving 10 units or less of any blood product < 24 hrs or 11-15 units < 48 hrs.vs.
- patients receiving 11-15 units of any blood product < 24 hrs. or 16-20 units < 48 hrs. vs.
- patients receiving 16-20 units of any blood product < 24 hrs. or 21-25 units < 48 hrs. vs.
- patients receiving more than 20 units of any blood product < 24 hrs. or more than 25 units < 48 hrs.
- Outcome predicted by a joint function (general interaction) of total plasma transfusion and total blood cell transfusion will be assessed in an exploratory way by inspection and by agnostic modelling in the mold of Multivariate Adaptive Regression Splines (MARS) and recursive partitioning, i.e. Classification And Regression Trees (CART).
- Redefine intervention and control group as 4th and 1st quartile of FFP:RBC ratio. Initially, the population will be divide into 4 groups according to quartiles and compared the population below 1st quartile with the population above the 4th quartile, which will define the low vs. the high FFP group, resp. However, to allow for stratification for operation type (ruptured AAA vs. intact AAA vs. occlusive disease) it may be necessary to adjust the percentile cut to retain power in the analyses. For instance, the population may be cut according to tertiles, or, if there is sufficient data, cut by quintiles (5 groups) or deciles (10 groups).
- Confine the population to patient with blood loss above 50 % of total blood volume (calculated by Naddler's equation accounting for sex, weight and height). If height and weight are not available, the registered blood loss must exceed 2 L in females and 2.5 L in males.
- Adjusting exclusively for calendar year, sex, age, Charlson's comorbidity index score, and center (ie, excluding priority and antithrombotic therapy).
MISSING DATA
Missing data will not be an issue for the number of blood transfusions because units of blood products transfused are used as an inclusion criterion. All remaining covariates are discrete, and missing data for each of those will be included as separate parameters (factor level).
STATISTICAL SIGNIFICANCE LEVEL
Bonferroni adjustment of the significance level will be applied to control for multiple testing.
With one primary and four secondary outcomes, only a P-value below 0.01 (0.05/5) will be considered statistically significant. A P-value between 0.01 and 0.05 will be considered borderline significant.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-FFP | – | Biological: Plasma transfusionPatients transfused with an FFP:RBC ratio of 2:3 to 3:3 (0.7 - 1.0) |
| Low-FFP | – | Biological: Plasma transfusionPatients transfused with an FFP:RBC ratio at or below 1:3 (0.0 - 0.3). |
Who may qualify
- Ages
- 41 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Open abdominal aortic repair with the insertion of prosthesis for either
- 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.
Key exclusion criteria (3 listed)
- Surgery time limited to < 50 minutes (DVR)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma transfusionTransfusion of allogeneic fresh frozen plasma or cryoprecipitate | Biological | High-FFP, Low-FFP |
Primary outcome
90-day survival
Time frame: First 90 days after index surgery
Survival data. Source: CPR
4 secondary outcomes
30-day survival
Time frame: First 30 days after index surgery
1-year survival
Time frame: 1 year after index surgery
Death or any major adverse events at 90-days
Time frame: First 90 days after index surgery
Number of days alive outside hospital within 90 days
Time frame: Day 90 after index surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Background: PubMed 26171897Desborough M, Sandu R, Brunskill SJ, Doree C, Trivella M, Montedori A, Abraha I, Stanworth S. Fresh frozen plasma for cardiovascular surgery. Cochrane Database Syst Rev. 2015 Jul 14;2015(7):CD007614. doi: 10.1002/14651858.CD007614.pub2.
- Background: PubMed 25647203Holcomb JB, Tilley BC, Baraniuk S, Fox EE, Wade CE, Podbielski JM, del Junco DJ, Brasel KJ, Bulger EM, Callcut RA, Cohen MJ, Cotton BA, Fabian TC, Inaba K, Kerby JD, Muskat P, O'Keeffe T, Rizoli S, Robinson BR, Scalea TM, Schreiber MA, Stein DM, Weinberg JA, Callum JL, Hess JR, Matijevic N, Miller CN, Pittet JF, Hoyt DB, Pearson GD, Leroux B, van Belle G; PROPPR Study Group. Transfusion of plasma, platelets, and red blood cells in a 1:1:1 vs a 1:1:2 ratio and mortality in patients with severe trauma: the PROPPR randomized clinical trial. JAMA. 2015 Feb 3;313(5):471-82. doi: 10.1001/jama.2015.12.
- Background: PubMed 17381616Johansson PI, Stensballe J, Rosenberg I, Hilslov TL, Jorgensen L, Secher NH. Proactive administration of platelets and plasma for patients with a ruptured abdominal aortic aneurysm: evaluating a change in transfusion practice. Transfusion. 2007 Apr;47(4):593-8. doi: 10.1111/j.1537-2995.2007.01160.x.
- Background: PubMed 20378142Mell MW, O'Neil AS, Callcut RA, Acher CW, Hoch JR, Tefera G, Turnipseed WD. Effect of early plasma transfusion on mortality in patients with ruptured abdominal aortic aneurysm. Surgery. 2010 Nov;148(5):955-62. doi: 10.1016/j.surg.2010.02.002. Epub 2010 Apr 7.
- Background: PubMed 28273299Mesar T, Larentzakis A, Dzik W, Chang Y, Velmahos G, Yeh DD. Association Between Ratio of Fresh Frozen Plasma to Red Blood Cells During Massive Transfusion and Survival Among Patients Without Traumatic Injury. JAMA Surg. 2017 Jun 1;152(6):574-580. doi: 10.1001/jamasurg.2017.0098.
- Background: PubMed 27605360Montan C, Hammar U, Wikman A, Berlin E, Malmstedt J, Holst J, Wahlgren CM. Massive Blood Transfusion in Patients with Ruptured Abdominal Aortic Aneurysm. Eur J Vasc Endovasc Surg. 2016 Nov;52(5):597-603. doi: 10.1016/j.ejvs.2016.07.023. Epub 2016 Sep 4.
- Background: PubMed 30380388Sperry JL, Guyette FX, Adams PW. Prehospital Plasma during Air Medical Transport in Trauma Patients. N Engl J Med. 2018 Nov 1;379(18):1783. doi: 10.1056/NEJMc1811315. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Aortic Aneurysm, Abdominal
Not yet recruitingObservational study
Aortic Size and Height Indices in Abdominal Aortic Aneurysms
Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm, Ruptured
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Enrolling by invitation
AneuFix - Prophylactic Sac Filling
Abdominal Aortic Aneurysm, Endoleak
Active, not recruiting
ANEUFIX for Endoleak Type II Repair
Abdominal Aortic Aneurysm, Endoleak
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
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.
Ole Pedersen, MD, PhD study director
Department of Clinical Immunology, Naestved Hospital, Denmark.
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 Aortic Aneurysm, Abdominal and Arterial Occlusive Diseases, run by Naestved Hospital at 1 site in Denmark.
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 6 inclusion and 3 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: finished, as of the sponsor's last update on 28 Jan 2021. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
90-day survival (time frame: First 90 days after index surgery). 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 NCT04514575, which also lists 7 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 28 Jan 2021.