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A clinical trial to study the effect of tranexaemic acid in head neck surgeries

A randomized controlled clinical trial to study the effect of tranexaemic acid in head neck surgery - none

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/10/010064
Enrollment
80
Registered
2017-10-12
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: C07- Malignant neoplasm of parotid gland Health Condition 2: null- Patients suffering with different head and neck cancers and fit to undergo surgery Health Condition 3: C775- Secondary and unspecified malignant neoplasm of intrapelvic lymph nodes

Interventions

Intervention1: Tranexaemic acid: Identical, prefilled and coded syringes with tranexaemic acid (100mg/ml) will be supplied to operating team by pharmacologist who will not have access to patient profi

Sponsors

Nil
Lead Sponsor
Dr Anamika Thakur MD
Collaborator
Dr D R Sharma MBBS MS
Collaborator
Dr N K Mohindroo MBBS MS
Collaborator
Dr R S Minhas MBBS MS
Collaborator
Dr Ramesh K Azad MBBS MS
Collaborator
Dr Vasanthalakshmi MS
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients (minimum of eighty patients) suffering with different head and neck tumor (benign or malignant with/without nodal metastasis) undergoing different head neck surgeries under general anaesthesia will be enrolled after obtaining informed consent. These patients will be enrolled in two groups with each group having control. Group 1: Patients undergoing total thyroidectomy, total parotidectomy, comprehensive or selective neck dissection with or without primary tumour excision Group 2: Patient undergoing thyroid lobectomy or hemithyroidectomy and superficial parotidectomy without neck dissection.

Exclusion criteria

Exclusion criteria: 1. A history of preoperative chemotherapy or radiotherapy. 2. Patients with allergic to tranexaemic acid 3. Any coagulopathy/bleeding disorder/deep vein thrombosis/peripheral vascular diseases. 4. Patients on anticoagulant / antiplatelet/ antifibrinolytic drugs 5. Coronary artery disease, chronic renal insufficiency, hematuria, Uncontrolled hypertension 6. Patients opting not to participate in the trial i.e. who do not give consent.

Design outcomes

Primary

MeasureTime frame
Effect of tranexaemic acid in reduction of postoperative surgical drainTimepoint: 3 days after surgery—

Countries

India

Contacts

Public ContactJagdeep S Thakur

Indira Gandhi Medical College

anujagdeep@yahoo.co.in91-177-2883590

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026