Effectiveness of ROTEM-based Coagulation Surveillance on Reducing Blood Product Utilization During Complex Spine Surgery

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Duke University

Status

Terminated

Conditions

Spine Surgery
Rotational Thrombo-elastometry (ROTEM)

Treatments

Procedure: Spine surgery
Device: ROTEM-based coagulation monitoring

Study type

Interventional

Funder types

Other

Identifiers

NCT02758184
Pro00070817

Details and patient eligibility

About

The Purpose of this study is to identify added value of Rotational thrombo-elastometry (ROTEM) intra-operative coagulation surveillance on reducing blood product use during major reconstructive spine surgery.

Full description

The aim of the study is to evaluate the effectiveness of intra-operative ROTEM-based coagulation monitoring on reducing total blood product use during complex spine surgery. The primary outcome will include estimated blood losses and blood product utilization during and after surgery (48 hours). Secondary outcomes also include hospital length of stay, and cost analysis of the 2 methodologies.

Enrollment

21 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age > 18 and < 80 years old.
  • Elective spine surgery cases, with a traditional open posterior approach and involving fusion of at least 5 levels.
  • Normal coagulation profile (PT/INR, aPTT) and normal platelets count on pre-operative evaluation.
  • Preoperative hemoglobin Level >10 g/dl.
  • OR time > 4 hours.
  • No contraindication for the use of anti-fibrinolytic therapy (Tranexamic acid).

Exclusion criteria

  • Age < 18 or age > 80 years old.
  • Anterior spine surgeries or posterior spine surgeries involving <5 levels.
  • Minimally invasive spine surgeries.
  • Patients with known coagulopathies or bleeding tendencies or patients with abnormal coagulation laboratory values at baseline.
  • Patients with Hemoglobin level of <10 g/dl on preoperative baseline laboratory values.
  • Trauma and Emergency spine surgeries.
  • Patients with spine malignancy diagnosis, either primary or metastatic.
  • OR time < 4 hours.
  • Patients who refuse to use allogenic blood products.
  • Patients with contraindications for the use of anti-fibrinolytic therapy.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

21 participants in 2 patient groups

ROTEM Group
Experimental group
Description:
Patients who are randomized to receive ROTEM
Treatment:
Device: ROTEM-based coagulation monitoring
Procedure: Spine surgery
Control Group
Other group
Description:
Patients who are randomized not to receive ROTEM
Treatment:
Procedure: Spine surgery

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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