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Plasma Transfusion in Major Vascular Surgery

NCT04514575 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 17000

Last updated 2021-01-28

No results posted yet for this study

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

Interventions

BIOLOGICAL

Plasma transfusion

Transfusion of allogeneic fresh frozen plasma or cryoprecipitate

Sponsors & Collaborators

  • Statens Serum Institut

    collaborator OTHER

  • Naestved Hospital

    lead OTHER

Principal Investigators

  • Ole Pedersen, MD, PhD · Department of Clinical Immunology, Naestved Hospital, Denmark.

Eligibility

Min Age
41 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-01-01
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04514575 on ClinicalTrials.gov