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Vascular Changes of Rotator Cuff Repair Augmented With a Whole Blood Fibrin Clot

NCT03577379 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2022-05-05

No results posted yet for this study

Summary

The goal of this study is to assess whether undergoing surgical repair of the rotator cuff with the additional intervention of whole blood fibrin clot will improve rotator cuff vascularization at the bone-tendon interface repair site and patient outcomes compared to those who do not receive the whole blood fibrin clot intervention.

Conditions

  • Rotator Cuff Tear

Interventions

OTHER

Whole Blood Fibrin Clot

For all patients assigned to the treatment group, 35mL of whole blood will be obtained during surgery by an anesthesiologist. 5 mL of the blood will be sent for pre-clot formation cell count evaluation for platelets, red blood cells and white blood cells. The remaining 30mL will be placed into a sterile container with a sintered glass cylinder supported by the lid for fibrin clot formation. The clot formation cups will be placed on a rotator at room temperature for 10 minutes at 125rpm. The fibrin clot will be removed and 5mL of the post-clot serum sent for post-clot formation cell count evaluation for platelets, red blood cells, and white blood cells.

Sponsors & Collaborators

  • Santa Barbara Cottage Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2022-04-25
Completion
2022-04-25

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03577379 on ClinicalTrials.gov