Plasma Transfusion in Major Vascular Surgery

NCT04514575 | Completed

• 1 other identifier: REG-144-2017
• Study Type: observational
• Target: 17,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Aneurysm, Abdominal; Arterial Occlusive Diseases

Outcome Measures

Primary Outcomes (1)

• 90-day survival

  Survival data. Source: CPR

  First 90 days after index surgery

Secondary Outcomes (4)

• 30-day survival

  First 30 days after index surgery

• 1-year survival

  1 year after index surgery

• Death or any major adverse events at 90-days

  First 90 days after index surgery

• Number of days alive outside hospital within 90 days

  Day 90 after index surgery

Study Arms (2)

High-FFP

Patients transfused with an FFP:RBC ratio of 2:3 to 3:3 (0.7 - 1.0)

Biological: Plasma transfusion

Low-FFP

Patients transfused with an FFP:RBC ratio at or below 1:3 (0.0 - 0.3).

Biological: Plasma transfusion

Interventions

Plasma transfusion BIOLOGICAL

Transfusion of allogeneic fresh frozen plasma or cryoprecipitate

High-FFP; Low-FFP

Eligibility Criteria

• Age: 41 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Naestved Hospital: lead
• Statens Serum Institut: collaborator

Study Sites (1)

Slagelse Hospital

Slagelse, Region Sjælland, 4200, Denmark

Location

Related Publications (7)

• 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.

  PMID: 26171897 BACKGROUND

• Holcomb 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.

  PMID: 25647203 BACKGROUND

• Johansson 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.

  PMID: 17381616 BACKGROUND

• Mell 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.

  PMID: 20378142 BACKGROUND

• Mesar 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.

  PMID: 28273299 BACKGROUND

• Montan 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.

  PMID: 27605360 BACKGROUND

• Sperry 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.

  PMID: 30380388 BACKGROUND

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Arterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Ole Pedersen, MD, PhD

  Department of Clinical Immunology, Naestved Hospital, Denmark.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: August 17, 2020
• Study Start: January 1, 1997
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: January 28, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)