New Device Could Prevent Severe Bleeding, Hemorrhage After Surgery

June 30, 2020

The iCoagLab test reports several coagulation metrics within minutes, whereas traditionally it can take several hours for coagulation defects to be detected.

Seemantini Nadkarni, PhD

Patients who have blood clotting after surgery or major injury could have severe bleeding or hemorrhage if they are not rapidly treated with blood transfusions, and using a new test called iCoagLab could help expedite the process.

Senior author Seemantini Nadkarni, PhD, and a team of investigators led by Massachusetts General Hospital developed a novel, inexpensive and portable device to quickly measure the ability of blood to properly clot. The new test, called iCoagLab, reports several coagulation metrics within minutes, whereas traditionally it could take several hours for a test to detect coagulation defects.

“Clinicians in the operating room or the ICU often walk a thin line to maintain the delicate balance between bleeding and coagulation,” Nadkarni, an associated professor at Harvard Medical School, said in a statement. “The iCoagLab innovation will likely advance clinical capability to rapidly identify patients with defective clotting at the point-of-care, assess risk of hemorrhage, and tailor treatments based on individual coagulation deficits to help prevent life-threatening bleeding in patients.”

Non-study staff from Massachusetts General Hospital collected whole blood samples from 270 patients undergoing conventional coagulation testing. Among the cohort, 92 patients with recorded coagulation testing values of activated partial thromboplastin time, lupus anticoagulant, fibrinogen and platelet count, and clinical notes on bleeding status were identified. The team categorized the patients as bleeding or at an elevated bleeding risk. Parameters of clotting included reaction time, clot progression time, clot progression rate, and maximum clot strength.

In an effort to get an accurate comparison between iCoagLab and thromboelastography, the measurements were conducted at the same time, and samples were treated in a similar manner. The setup for iCoagLab was based on Laser Speckle Rheology principles. The clot viscoelasticity profile was obtained by calculating and reporting the relative change in the viscoelastic modulus of whole blood during coagulation.

For all patients included, the investigators noted a good correlation between iCoagLab- and thromboelastography-derived parameters (P <.001). Multivariate analysis demonstrated that iCoagLab-derived parameters identified bleeding risk with a sensitivity (94%) identical to, and diagnostic accuracy (89%) higher than thromboelastography. The device iCoagLab had a specificity of 77%, which was significantly higher than that of the thromboelastography (69%).

Coagulation testing is often unreliable for the timely assessment of coagulation status. Therefore, bleeding management and transfusion dosing decisions are based on empirical data and result in the overuse of blood products and increasing the risk of post-operative complications.

The iCoagLab innovation serves a clinical need by providing a platform to rapidly and comprehensively quantify coagulation profiles using small volumes of whole blood. Using the device takes half the time at less than a percent of the cost of a typical thromboelastography or rotational thromboelastometry tools.

“By rapidly and comprehensively permitting blood coagulation profiling, the iCoagLab innovation is likely to advance the capability to identify patients with elevated risk for bleeding, with the ultimate goal of preventing life-threatening hemorrhage,” Nadkarni and the study authors concluded.

The study, “Comprehensive Blood Coagulation Profiling in Patients Using iCoagLab: Comparison Against Thromboelastography,” was published online in the journal Thrombosis and Haemostasis.