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Search / Trial NCT07012837

Transfusion Reduction in High-Bleeding-Risk Cardiac Surgery With Desmopressin

Launched by IMAM ABDULRAHMAN BIN FAISAL UNIVERSITY · Jun 1, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Adult Cardiac Surgery Cardiopulmonary Bypass High Bleeding Risks Desmopressin Prophylactic Point Of Care Coagulation Tests

ClinConnect Summary

This clinical trial is studying whether a medication called desmopressin can help reduce bleeding and the need for blood transfusions in adults who are at high risk of bleeding during elective cardiac surgery. Desmopressin is known to help with blood clotting by promoting the release of certain factors that help blood clot properly. The researchers want to see if giving desmopressin before and during surgery can make a difference compared to a placebo, which is a substance with no active medication in it. They are particularly interested in patients who have conditions that put them at a higher risk for bleeding, such as those with previous heart surgeries, certain blood disorders, or those taking specific medications that affect blood clotting.

To be eligible for this trial, participants need to be 18 years or older and scheduled for elective cardiac surgery that requires the use of a heart-lung machine (CPB). Key factors that might qualify someone as high-risk include having low blood platelet counts, certain liver or kidney issues, or a higher expected risk of bleeding based on preoperative assessments. If chosen for the trial, participants can expect to receive either desmopressin or a placebo during their surgery and will be monitored for outcomes like bleeding, the need for blood transfusions, and overall recovery. It's important to note that this trial is not yet recruiting participants, and it aims to provide insights that could lead to better outcomes and lower costs for patients undergoing high-risk heart surgeries.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Adult 18 years or older.
  • Scheduled for any type of elective cardiac surgery.
  • Using CPB.
  • General anesthesia is provided in an endotracheally intubated patient.
  • A high risk of postoperative bleeding is defined as any of the following \[21-23\];
  • Redo or repeated surgery.
  • Treatment with platelet P2Y12 receptor--inhibiting drugs was discontinued for 7 days (ticlopidine, clopidogrel, and prasugrel) or 5 days (ticagrelor).
  • Any known coagulation disorders.
  • Hypofibrinogenemia less than 150 mg/dl.
  • Platelet count \<100.000 cells/μL.
  • Chronic renal failure, whether dialysis-dependent or not.
  • Liver cell failure Child-Pugh class B or C or the Model for End-Stage Liver Disease (MELD) \>=29
  • Infective endocarditis.
  • Acute type-A aortic dissection.
  • Expected surgery with CPB time longer than 150 minutes.
  • Preoperative estimated Papworth Bleeding Risk Score of 8% or greater \[23\].
  • Exclusion Criteria:
  • Planned for cardiac surgery without CPB;
  • Planned for a combined coronary revascularization surgery and a valve or intra-cardiac surgery;
  • Pregnancy;
  • Consent for another interventional study during anesthesia;
  • No written informed consent;
  • Preoperative need for mechanical circulatory support;

About Imam Abdulrahman Bin Faisal University

Imam Abdulrahman Bin Faisal University (IAU) is a distinguished educational institution located in Saudi Arabia, dedicated to advancing healthcare through innovative research and clinical trials. With a commitment to excellence in medical education and community health, IAU actively engages in multidisciplinary studies that aim to enhance patient outcomes and contribute to evidence-based practices. The university's clinical trial initiatives are supported by a robust framework of ethical standards and regulatory compliance, ensuring the integrity and safety of its research endeavors. By fostering collaboration among researchers, healthcare professionals, and industry partners, IAU aims to drive significant advancements in medical science and improve the overall quality of healthcare delivery.

Locations

Dammam, Eastern, Saudi Arabia

Patients applied

0 patients applied

Trial Officials

Mohamed R El Tahan, MD

Study Chair

Imam Abdulrahman Bin Faisal University

Fahad Makhdoum, MD

Principal Investigator

Imam Abdulrahman Bin Faisal University

Yasser F ElGhoneimy, MD

Study Director

Imam Abdulrahman Bin Faisal University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported