Is Plasma Transfusion Beneficial Prior to Low-Risk Procedures in Hospitalized Patients With Blood Clotting Abnormalities?

Restrictive Versus Liberal Fresh Frozen Plasma Transfusion Prior to Low-Risk Invasive Procedures in Hospitalized Patients.

Blood clotting abnormalities or problems that happen during surgery ? even minor surgery ? are serious because of the possibility of serious bleeding that cannot be stopped. The current standard practice for people with clotting abnormalities is to transfuse additional blood before the surgery, in an effort to decrease bleeding problems. However, transfusing blood before the surgery is not very effective in decreasing bleeding complications. In addition, it may be associated with other complications, including fluid buildup and swelling in the lungs. For this study, a person with a mild clotting problem is defined as one with an INR (International Normalized Ratio) between 1.5 and 3. Severe clotting is defined as an INR greater than 3. This study will aim to test if limiting or restricting transfusion for those patients with severe clotting problems (an INR greater than 3) will result in fewer transfusion problems and fewer unnecessary transfusions in comparison with the current, more liberal, transfusion use for all patients with both mild and severe clotting problems (an INR greater than 1.5).The investigators will also determine if liberal blood transfusion decreases the risk of bleeding after surgical procedures.

Study Overview

• Status: Completed
• Conditions: Surgical Procedures, Minimally Invasive; Blood Coagulation, Disorders
• Intervention / Treatment: Drug: Fresh Frozen Plasma Transfusion

Detailed Description

While the restrictive red cell transfusion practice has become a standard of care in the acutely ill, data on the use of fresh frozen plasma (FFP) are limited. FFP transfusion may not only be poorly effective in prevention of bleeding complications but is associated with significant complications. In a retrospective cohort of critically ill non-surgical patients with abnormal international normalized ratio (INR), we have observed significant variability in the practice of FFP transfusion. Rather than a benefit with liberal use, more adverse effects were observed, in particular pulmonary edema and acute lung injury. Our overall goal is to improve the safety of blood product transfusion and prevent pulmonary complications. Here we propose a randomized clinical trial of restrictive (INR 1.6-3) versus liberal (FFP transfusion to keep INR < 1.6) FFP transfusion prior to commonly performed invasive procedures (thoracocentesis, abdominal paracentesis and central venous cannulation). We will use the following outcome measures to compare the differences between the two groups: 1. New onset pulmonary edema; 2. Postprocedural bleeding complications; 3. Number of blood product transfusions; 4. Hospital mortality and 5. Length of intensive care unit and hospital stay. The results of this study will form the basis for future multicenter clinical trials with implications for worldwide transfusion practice.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion:

• Consenting hospitalized adult
• (>18 years)
• Patients with abnormal INR (INR 1.6-3) due to either vitamin K depletion or antagonism (Coumadin and/or broad spectrum antibiotics) or liver insufficiency
• Patients who are about to undergo one of the three common minimally invasive procedures (thoracocentesis, abdominal paracentesis, and central vein cannulation)

Exclusion:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
New onset pulmonary edema

Secondary Outcome Measures

Outcome Measure
Hospital mortality
Postprocedural bleeding complications
Number of blood product transfusions
Length of intensive care unit and hospital stay

Collaborators and Investigators

• Sponsor: Mayo Clinic

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: August 4, 2009
• First Submitted That Met QC Criteria: August 5, 2009
• First Posted (Estimate): August 6, 2009

Study Record Updates

• Last Update Posted (Estimate): November 16, 2009
• Last Update Submitted That Met QC Criteria: November 13, 2009
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Other Study ID Numbers: 2247-05