Clinical Trials Logo

Clinical Trial Summary

Heparin-induced thrombocytopenia (HIT) is an immune-mediated adverse drug reaction to heparin products which results in a prothrombotic state. Heparin-induced thrombocytopenia generally occurs several days after the start of unfractionated heparin or low molecular weight heparin and is diagnosed based on clinical presentation, and presence of thrombocytopenia. HIT has an incidence of 0.1% to 5% and if recognized early can help prevent major complications. As of November 2014, the responsibility for documenting heparin allergies in the electronic medical record (EMR) has shifted from the physician/medical resident to the pharmacy resident. The purpose of this study is to compare the number, rate, and appropriateness of heparin allergy documentation in order to help decrease adverse medical events related to heparin.


Clinical Trial Description

Heparin-induced thrombocytopenia is a unique form of drug induced thrombocytopenia associated with increased clotting risk. The incidence of HIT ranges from 0.1% to 5%. Heparin-induced thrombocytopenia occurs when an antibody forms a complex with platelet factor 4 and heparin. This complex activates platelets which increases the risk of thrombus formation. Normally, HIT presents 5 to 14 days after exposure, but can occur with heparin exposure within the past 100 days. The presentation of HIT is often first suspected secondary to a decrease in platelet counts of 50% or more from baseline. At Rush University Medical Center (RUMC), HIT is diagnosed through a combination of clinical factors and laboratory tests. When HIT is first suspected, a 4T HIT score, which is used to estimate the probability of true HIT, is calculated. The following score ranges correspond to the probability of true HIT; score of 0-3 indicates a low probability, score of 4-5 indicates an intermediate probability, and a score of 6-8 indicates a high probability of true HIT. If the score indicates a likelihood of HIT, a HIT-Ab is sent off. This test has a sensitivity of more than 95% and a specificity of 74% to 86%. Accordingly, if this HIT-Ab test result is negative, HIT is ruled out. If the result is equivocal or positive, a confirmatory Serotonin Release Assay (SRA) test should be performed (sensitivity of 89% to 100% and a specificity of 88 % to 100%). Prior to 2014, there was no formal process for evaluation of patients with HIT. In November of 2014, an EMR tool was created in an effort to improve heparin allergy documentation and HIT management. This EMR tool prompts the medical team to perform the 4T score, displays the appropriate HIT labs, alternative anticoagulation strategies, instructs the nurse to apply an allergy bracelet, and notifies the pharmacy resident through the order verification queue. The pharmacy resident then performs an independent 4T score, discontinues all heparin products, documents the heparin allergy in the medical record, and assesses the need for alternative anticoagulation. Many studies have shown the value of the 4T HIT scoring system and the use of pharmacists in reducing the inappropriate use of alternative anticoagulation and unnecessary testing. Pharmacists have helped to improve patient outcomes and decrease costs associated with HIT. The purpose of this study is to evaluate the impact of an EMR tool and pharmacy residents on allergy documentation and the management of HIT. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05439265
Study type Observational
Source Rush University Medical Center
Contact
Status Completed
Phase
Start date January 2014
Completion date April 2017

See also
  Status Clinical Trial Phase
Recruiting NCT04003220 - Idiopathic Chronic Thrombocytopenia of Undetermined Significance : Pathogenesis and Biomarker
Completed NCT02948283 - Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia Phase 1
Recruiting NCT03633019 - High-dose Use of rhTPO in CIT Patients Phase 4
Recruiting NCT06087198 - Clinical Performance Evaluation of T-TAS®01 HD Chip
Recruiting NCT03605511 - TTP and aHUS in Complicated Pregnancies
Active, not recruiting NCT03688191 - Study of Sirolimus in CTD-TP in China Phase 4
Completed NCT02845609 - Efficacy of Sialic Acid GNE Related Thrombocytopenia Phase 2
Recruiting NCT02244658 - Recombinant Human Thrombopoietin (rhTPO) in Management of Chemotherapy-induced Thrombocytopenia in Acute Myelocytic Leukemia Phase 3
Recruiting NCT02241031 - Megakaryocytic Progenitor Cells for Prophylaxis and Treatment of Thrombocytopenia Phase 2/Phase 3
Completed NCT01356576 - Effect of Hemodialysis Membranes on Platelet Count N/A
Terminated NCT01368211 - Mirasol-Treated Platelets - (Pathogen Reduction Extended Storage Study) Phase 2/Phase 3
Unknown status NCT01196884 - Immune Thrombocytopenia (ITP) Immune-Genetic Assessment
Completed NCT00039858 - Evaluation of Argatroban Injection in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin Phase 4
Completed NCT00787241 - Platelet Count Trends in Pre-eclamptic Parturients N/A
Completed NCT00001533 - Treatment of T-Large Granular Lymphocyte (T-LGL) Lymphoproliferative Disorders With Cyclosporine Phase 1
Not yet recruiting NCT06036966 - The Efficacy and Safety of Hetrombopag in Primary Prevention of Thrombocytopenia Induced by the Niraparib Maintenance in Advanced Ovarian Cancer Patients Phase 2
Completed NCT01791101 - Eltrombopag in Patients With Delayed Post Transplant Thrombocytopenia. Phase 2
Recruiting NCT06053021 - Antiplatelet Therapy for AIS Patients With Thrombocytopenia N/A
Recruiting NCT03701217 - Eltrombopag Used in Thrombocytopenia After Comsolidation Therapy in AML Phase 2/Phase 3
Not yet recruiting NCT05958511 - Assessment of Risk Factors and Outcome of Thrombocytopenia in ICU Patients