Effect of Thromboelastography (device used to test for blood clot formation and lysis) versus conventional treatment on need of drugs (which promote clot formation) and need of blood products during elective complex spine surgery- a randomized study.

Effect of Thromboelastography Guided versus Conventional Haemostatic Therapy on Intraoperative Antifibrinolytic and Transfusion requirement in Elective complex spine surgeries- A Randomized, Parallel Arm study.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/02/080224

Enrollment

256

Registered

2025-02-10

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G952- Other and unspecified cord compression

Interventions

Intervention1: Thromboelastography guided hemostatic therapy.: Baseline Thromboelastography (TEG) will be done at time of securing intravenous cannula in preoperative room. TEG will be done every two

Eligibility

Inclusion criteria

Inclusion criteria: Adolescent and adult patients American Society of Anesthesiologists (ASA) Physical status I-III classification BMI less than 35Kg per msquare Undergoing instrumented spine surgery of thoracic or lumbar spine (between T1 and S1) by a posterior midline approach Providing informed consent to participate in the surgery.

Exclusion criteria

Exclusion criteria: History of allergy or hypersensitivity to Tranexamic acid. History of frequent bleeding, past or family history of thromboembolism (stroke, Non-fatal myocardial infarction, pulmonary embolism, bowel infarction) Current treatment with anticoagulants other than aspirin Laboratory values of Hemoglobin less than 10gm/dl, Serum creatinine more than 1.5 mg per dl, Platelet count less than 1.5 lakhs per cumm, International Normalized Ratio (INR) more than1.4, activated partial thromboplastin time more than 38 s. Patients with a neoplastic, infectious spinal condition or polytrauma. Minimally invasive spine surgery like endoscopic discectomy.

Design outcomes

Primary

Measure	Time frame
Total dose of tranexamic acid- mg per kg Weighted average Tranexamic acid given per kg per hour. Proportion of patient needing PRBC transfusionTimepoint: During surgery	—

Secondary

Measure	Time frame
Total number and type of blood products transfused in intervention versus comparator groupTimepoint: first 24 hours, first week of surgery;Incidence of Thromboembolic events & average Wells score for Deep venous thrombosis.Timepoint: First week after surgery;Incidence of hypercoagulability based on coagulation index & fibrinolysis shutdown based on Lysis 30 in both groupsTimepoint: Postoperative day one & three	—

Measure

Time frame

Total number and type of blood products transfused in intervention versus comparator groupTimepoint: first 24 hours, first week of surgery;Incidence of Thromboembolic events & average Wells score for Deep venous thrombosis.Timepoint: First week after surgery;Incidence of hypercoagulability based on coagulation index & fibrinolysis shutdown based on Lysis 30 in both groupsTimepoint: Postoperative day one & three

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Countries

India

Contacts

Public ContactSunaina Tejpal Karna

AIIMS Bhopal

rehan.ortho@aiimsbhopal.edu.in7982360432

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026