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ROLE OF VITAMIN-K & TRANEXAMIC ACID IN PREVENTING BLOOD LOSS IN PRIMARY TOTAL JOINT ARTHROPLASTY: RCT OF COMBINED V/S ISOLATED REGIMENS

ROLE OF VITAMIN-K & TRANEXAMIC ACID IN PRIMARY TOTAL JOINT ARTHROPLASTY: RCT OF COMBINED V/S ISOLATED REGIMENS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/01/049003
Enrollment
80
Registered
2023-01-13
Start date
Unknown
Completion date
Unknown
Last updated
2023-02-06

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

Conditions

Health Condition 1: M129- Arthropathy, unspecified Health Condition 2: M169- Osteoarthritis of hip, unspecified Health Condition 3: M179- Osteoarthritis of knee, unspecified Health Condition 4: M059- Rheumatoid arthritis with rheumatoid factor, unspecified Health Condition 5: M069- Rheumatoid arthritis, unspecified

Interventions

Intervention1: 1. Inj. Vitamin-K (Vit-K) 2. Inj. Tranexamic Acid (TEXA): Group D: TEXA + Vit-K: 2 doses of 10mg/dose, 12 PM and 7AM pre-op & 2 doses of 1 gm/dose, 12 PM and 7 AM pre-op & 3 doses of 1

Sponsors

Dr Madhav Chowdhry
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Patients undergoing Primary THA - Patients undergoing Primary TKA

Exclusion criteria

Exclusion criteria: - Revision TKA - Revision THA - Any coagulation abnormality - History of deep vein thrombosis (DVT) or pulmonary embolism (PE) - Contraindication to Vitamin-K / Tranexamic Acid therapy: History of seizures, abnormal INR, hypersensitivity to drug

Design outcomes

Primary

MeasureTime frame
Total Blood Loss during surgery Timepoint: preoperative 1 day prior, postoperative day 3 (during 72 hours time period after surgery).—

Secondary

MeasureTime frame
Assessment for DVT/PETimepoint: preoperative 1 day prior, postoperative day 1, postoperative day 3, postoperative day 14, postoperative week 6;Change in D-dimer levelsTimepoint: preoperative 1 day prior, postoperative day 1, postoperative day 3, postoperative day 14, postoperative week 6;Change in hematocrit levelsTimepoint: preoperative 1 day prior, postoperative day 1, postoperative day 3, postoperative day 14, postoperative week 6;Change in hemoglobin levelsTimepoint: preoperative 1 day prior, postoperative day 1, postoperative day 3, postoperative day 14, postoperative week 6;Change in Range of MotionTimepoint: preoperative 1 day prior, postoperative day 1, postoperative day 3, postoperative day 14, postoperative week 6;Change in undercarboxylated-osteocalcin (uc-oc) levelsTimepoint: preoperative 1 day prior;Change in walking distanceTimepoint: preoperative 1 day prior, postoperative day 1, postoperative day 3, postoperative day 14, postoperative week 6;Number of participants requiring blood transfusionTimepoint: Up to 72 hours after surgery—

Countries

India

Contacts

Public ContactDr Madhav Chowdhry

Jawaharlal Nehru Medical College

absabir@hotmail.com9837366082

Outcome results

None listed

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