Postoperative Initiation of Thromboprophylaxis in patients with Cushing's Disease (PIT-CD): a randomized controlled trial
Pituitary surgical intervention remains the preferred treatment for Cushing's disease (CD) while postoperative venous thromboembolism (VTE) is a significant risk. Whether to prescribe pharmacological thromboprophylaxis presents a clinical dilemma, balancing the benefit of reducing VTE risk with the potential for increasing hemorrhagic events in these patients. Currently, strong evidence and established protocols for routine pharmacological thromboprophylaxis in this population are lacking. Therefore, a randomized, controlled trial is warranted to determine the efficacy and safety of combined pharmacological and mechanical thromboprophylaxis in reducing postoperative VTE risk in patients with CD.
This investigator-initiated, multi-center, prospective, randomized, open-label trial with blinded outcome assessment aims to evaluate the efficacy and safety of combined pharmacological and mechanical thromboprophylaxis compared to mechanical thromboprophylaxis alone in postoperative patients with CD. A total of 206 patients diagnosed with CD who will be undergoing transsphenoidal surgery will be randomized in a 1:1 ratio to receive either combined pharmacological and mechanical thromboprophylaxis (intervention) or mechanical thromboprophylaxis only (control). The primary outcome is the risk of VTE within 12 weeks following surgery.
This trial represents a significant milestone in evaluating the efficacy of combined pharmacological and mechanical prophylaxis in reducing VTE events in postoperative CD patients.
ClinicalTrials.gov Identifier: NCT04486859, first registered on 22 July 2020.
Cushing’s disease; Deep vein thrombosis; Pituitary adenoma; Pulmonary embolism; Venous thromboembolism.
© 2025. The Author(s).
Declarations. Ethics approval and consent to participate {24}: This study will be conducted in accordance with the principles of the Helsinki Declaration and Good Clinical Practice. The first approval from the Institutional Review Board of Huashan Hospital was obtained in June 2020 (KY2020–794). Written informed consent will be obtained from all study participants (Supplement). Consent for publication {32}: No identifying images or other personal or clinical details of participants are presented here or will be included in reports of the trial results. Competing interests {28}: The authors declare that they have no competing interests.
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