Blood Coagulation Disorders Clinical Trial
Official title:
A Prospective Study of Airless Tubing in an Inpatient Acute Hemodialysis Unit in Hospitalized Patients in a Large Medical Center
NCT number | NCT02086682 |
Other study ID # | 13-003161 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 2014 |
Est. completion date | August 2015 |
Verified date | May 2019 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The introduction of unfractionated heparin (UFH), which prevents clotting of the
extracorporal circuit, was one of the key advances that led to the rapid development and
expansion of hemodialysis services. However, anticoagulation during hemodialysis of the
patient at high risk for bleeding remains a frequently encountered problem in both inpatient
and outpatient dialysis practice.
Streamline bloodlines are designed to eliminate blood-air contact. This is thought to help
reduce heparin use and decrease clotting rates. The goal of this study was to prospectively
examine impact of the Streamline airless blood tubing set, in an inpatient setting, on
dialysis circuit clotting rates, anticoagulation use, and dialysis efficiency.
Status | Completed |
Enrollment | 338 |
Est. completion date | August 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - All adult non-pregnant patients requiring inpatient hemodialysis at our center during the recruitment period until the target sample of dialysis sessions (n=1200) was reached. Exclusion Criteria: - Pregnant females - Children |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic Hospital, Saint Marys Campus | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Marie Hogan | NxStage Medical |
United States,
Safadi S, Albright RC Jr, Dillon JJ, Williams AW, Alahdab F, Brown JK, Severson AL, Kremers WK, Ryan MA, Hogan MC. Prospective Study of Routine Heparin Avoidance Hemodialysis in a Tertiary Acute Care Inpatient Practice. Kidney Int Rep. 2017 Mar 16;2(4):69 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clotting of Extracorporeal Dialysis Circuit | Each dialysis session was prospectively observed for Clotting of Extracorporeal Dialysis Circuit. Events were defined as interruption of hemodialysis session, loss of the hemodialysis circuit, or inability to return blood to the patient upon rinse back. | During the dialysis session, approximately 211 minutes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT02239991 -
Management of Perioperative Coagulopathy With Thromboelastometry (ROTEM) in Liver Transplant
|
N/A | |
Completed |
NCT01435304 -
The Effect of the Hemobag® Ultrafiltration System on Blood Conservation and Coagulation After Cardiopulmonary Bypass
|
N/A | |
Completed |
NCT00969319 -
Effekt-2 - Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Latin America
|
N/A | |
Completed |
NCT00091494 -
Socioeconomic Patterning of Inflammation and Hemostasis - Ancillary to MESA
|
N/A | |
Completed |
NCT00005481 -
Epidemiology of Impaired Coagulant Balance in Diabetes
|
N/A | |
Recruiting |
NCT02379104 -
ROTEM® Sigma Performance Evaluation - Method Comparison With Predicate Device and Reference Intervals
|
N/A | |
Withdrawn |
NCT02774317 -
Pilot Study to Compare Fresh Frozen Plasma With 24-Hour Plasma in Babies Up to Age Six Months
|
Phase 4 | |
Recruiting |
NCT01930916 -
Accuracy of a Portable International Normalized Ratio Monitor in Elderly Patients
|
N/A | |
Completed |
NCT00168090 -
Study of Safety and Efficacy of Antihemophilic Factor/Von Willebrand Factor Complex in Surgical Subjects With Von Willebrand Disease (vWD)
|
Phase 4 | |
Completed |
NCT01787552 -
A Phase Ib/II Dose-finding Study to Assess the Safety and Efficacy of LDE225 + INC424 in Patients With MF
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT02782338 -
The Effect of Voltaren-ophtha 0.1% Eye Drops on INR Levels (International Normalized Ratio) in Patients Taking Warfarin
|
N/A | |
Unknown status |
NCT01349712 -
Study to Test the Accuracy of a Prototype Handheld PT/INR Device
|
N/A | |
Completed |
NCT01143909 -
Transfusion of Fresh Frozen Plasma in Non-bleeding Intensive Care Unit (ICU) Patients
|
N/A | |
Recruiting |
NCT04762550 -
Thrombin Generation in Liver Transplant Surgery
|
||
Withdrawn |
NCT01221389 -
Study Using Plasma for Patients Requiring Emergency Surgery
|
Phase 4 | |
Withdrawn |
NCT00233246 -
Fresh-Frozen Plasma Infusions to Reduce Risk of Bleeding Related to Invasive Procedures
|
Phase 3 | |
Recruiting |
NCT03884725 -
Fibrinogen Concentrate In Children Cardiac Surgery 2
|
Phase 4 | |
Completed |
NCT00086476 -
Study of Megakaryocytes From Patients With Abnormal Platelet Vesicles
|
N/A | |
Completed |
NCT00516126 -
Goal-orientated Therapy of Perioperative Disturbance in Hemostasis in Cardiac Surgery
|
Phase 4 | |
Completed |
NCT00708435 -
Efficacy and Safety Study of BERIPLEX® P/N (Kcentra) Compared With Plasma in Patients With Acute Major Bleeding Caused by Anticoagulant Therapy
|
Phase 3 |