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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34HL125804-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Pittsburgh | OTHER |
| Johns Hopkins University | OTHER |
| University of Washington | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) |
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The purpose of this study is to evaluate prophylactic fresh frozen plasma transfusion in patients with moderately elevated international normalized ratios (INR) prior to undergoing an invasive procedure.
Fresh frozen plasma is used very frequently in the US. Many plasma transfusions are given prior to a procedure in order to correct perceived bleeding risk, yet there is little evidence to support that use of plasma reduces bleeding. There has never been an adequately powered trial to establish the efficacy of plasma and document the risks. This pilot study will evaluate the feasibility of conducting a research protocol that will lead to a large scale clinical trial designed to evaluate the treatment effectiveness of prophylactic plasma transfusion in patients with moderately elevated INRs prior to undergoing an invasive procedure outside of the operating room.
Study subjects will be randomly allocated to either receive either plasma transfusion prior to the procedure, or to no treatment. Study outcomes will be compared between the two study arms. Recruitment rates, protocol adherence, and rates of study outcomes will be assessed to determine the feasibility of the large scale trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fresh frozen plasma transfusion | Experimental | Pre-procedure fresh frozen plasma transfusion (15 cc per Kg, range 10-20 cc/Kg, to a maximum of 5 units) |
|
| No transfusion | No Intervention | No transfusions prior to the procedure |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fresh frozen plasma transfusion | Biological | Pre-procedure fresh frozen plasma transfusion (15 cc per Kg to a maximum of 5 units) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin Level | Change from pre-procedure hemoglobin to lowest within 2 days after procedure | within 2 days post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Red Blood Cell Transfusions | Differences in number of units of red blood cell transfusions between the two study arms | within 2 days post procedure |
| Number of Participants With Transfusion Associated Cardiac Overload (TACO) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey L Carson, MD | Rutgers Robert Wood Johnson Medical School | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University, The Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States | ||
| Robert Wood Johnson University Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fresh Frozen Plasma Transfusion | Pre-procedure fresh frozen plasma transfusion (15 cc per Kg, range 10-20 cc/Kg, to a maximum of 5 units) Fresh frozen plasma transfusion: Pre-procedure fresh frozen plasma transfusion (15 cc per Kg to a maximum of 5 units) |
| FG001 | No Transfusion | No transfusions prior to the procedure |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fresh Frozen Plasma Transfusion | Pre-procedure fresh frozen plasma transfusion (15 cc per Kg, range 10-20 cc/Kg, to a maximum of 5 units) Fresh frozen plasma transfusion: Pre-procedure fresh frozen plasma transfusion (15 cc per Kg to a maximum of 5 units) |
| BG001 | No Transfusion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Hemoglobin Level | Change from pre-procedure hemoglobin to lowest within 2 days after procedure | Posted | Mean | Standard Deviation | g/dL | within 2 days post procedure |
|
In-hospital (for up to 7 days)
Adverse events were captured via daily medical record review
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fresh Frozen Plasma Transfusion | Pre-procedure fresh frozen plasma transfusion (15 cc per Kg, range 10-20 cc/Kg, to a maximum of 5 units) Fresh frozen plasma transfusion: Pre-procedure fresh frozen plasma transfusion (15 cc per Kg to a maximum of 5 units) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey L Carson, MD | Rutgers, The State University of New Jersey | 732-235-7122 | Jeffrey.Carson@Rutgers.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 19, 2017 | Jul 1, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 19, 2018 | Jul 1, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001778 | Blood Coagulation Disorders |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| NIH |
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Difference in rates between the two study arms
| within 2 days post procedure |
| Number of Participants With Transfusion Related Acute Lung Injury (TRALI). | Difference in rates between the two study arms | with 2 days post procedure |
| Number of Participants With Major Bleed | 2g/dL or greater fall in hemoglobin level | with 2 days post procedure |
| Change in International Normalized Ratio (INR) Level Post Procedure | Change from pre-procedure INR level | day of procedure |
| Change in INR Level Day 1 | Change from pre-procedure INR level | day 1 post procedure |
| Change in INR Level Day 2 | Change from pre-procedure INR level | day 2 post procedure |
| Mortality (Number of Participants) | Death | in-hospital up to 7 days |
| Number of Participants With Infection | Pneumonia or blood stream infection | within 2 days post procedure |
| Number of Participants With ICU Admission | new admission to the intensive care unit | within 2 days post procedure |
| New Brunswick |
| New Jersey |
| 08903 |
| United States |
No transfusions prior to the procedure |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Liver disease | Count of Participants | Participants |
|
| Hypertension | Count of Participants | Participants |
|
| Diabetes | Count of Participants | Participants |
|
| Coronary artery disease | Count of Participants | Participants |
|
| Congestive heart failure | Count of Participants | Participants |
|
| Chronic Obstructive Pulmonary Disease (COPD) | Count of Participants | Participants |
|
| Thromboembolism | Count of Participants | Participants |
|
| Prior history of bleeding | Count of Participants | Participants |
|
| Metastatic carcinoma | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Number of Red Blood Cell Transfusions | Differences in number of units of red blood cell transfusions between the two study arms | Posted | Median | Inter-Quartile Range | units | within 2 days post procedure |
|
|
|
| Secondary | Number of Participants With Transfusion Associated Cardiac Overload (TACO) | Difference in rates between the two study arms | Posted | Count of Participants | Participants | within 2 days post procedure |
|
|
|
| Secondary | Number of Participants With Transfusion Related Acute Lung Injury (TRALI). | Difference in rates between the two study arms | Posted | Count of Participants | Participants | with 2 days post procedure |
|
|
|
| Secondary | Number of Participants With Major Bleed | 2g/dL or greater fall in hemoglobin level | Posted | Count of Participants | Participants | with 2 days post procedure |
|
|
|
| Secondary | Change in International Normalized Ratio (INR) Level Post Procedure | Change from pre-procedure INR level | Posted | Mean | Standard Deviation | ratio | day of procedure |
|
|
|
| Secondary | Change in INR Level Day 1 | Change from pre-procedure INR level | Posted | Mean | Standard Deviation | ratio | day 1 post procedure |
|
|
|
| Secondary | Change in INR Level Day 2 | Change from pre-procedure INR level | Posted | Mean | Standard Deviation | ratio | day 2 post procedure |
|
|
|
| Secondary | Mortality (Number of Participants) | Death | Posted | Count of Participants | Participants | in-hospital up to 7 days |
|
|
|
| Secondary | Number of Participants With Infection | Pneumonia or blood stream infection | Posted | Count of Participants | Participants | within 2 days post procedure |
|
|
|
| Secondary | Number of Participants With ICU Admission | new admission to the intensive care unit | Posted | Count of Participants | Participants | within 2 days post procedure |
|
|
|
| 1 |
| 27 |
| 2 |
| 27 |
| 0 |
| 27 |
| EG001 | No Transfusion | No transfusions prior to the procedure | 0 | 30 | 3 | 30 | 0 | 30 |
| Congestive Heart Failure | Cardiac disorders | Systematic Assessment |
|
| Blood Stream Infrection | Infections and infestations | Systematic Assessment |
|
| Septic Shock | Infections and infestations | Systematic Assessment |
|
| Liver Failure | Hepatobiliary disorders | Systematic Assessment |
|
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